Published by the Drug Enforcement Administration
Office of Forensic Sciences Washington, D.C. 20537

The U. S. Attorney
General has determined that the publication of this periodical is
necessary in the transaction of the public business required by the
Department of Justice. Information, instructions, and disclaimers
are published in the January issues.

VOL. XXXVI, NO. 6 June 2003

- INTELLIGENCE ALERT -

"HOMEMADE" CHOCOLATES CONTAINING PSILOCYBIN
MUSHROOMS
APPEARING ACROSS THE UNITED STATES

- RESPONSES REQUESTED -

Editor's
Preface: In April and May 2003, the DEA Office of Forensic Sciences
received multiple reports of homemade chocolates containing
ground-up psilocybin mushroom parts. Three of the reports were from
State and Local forensic laboratories and/or police departments in
Ohio, Oregon, and Rhode Island. The fourth was reported by the DEA
Mid-Atlantic Laboratory (Largo, Maryland), and was seized in
Virginia. Additionally, a similar report concerning a seizure in
Vail, Colorado was published in the National Drug Intelligence
Center's (NDIC's) April 29, 2003 issue of the Narcotics Digest
Weekly. The NDIC report also included a summary brief of a
number of similar seizures dating back as far as two years.

In several
cases, the seizures were multi-kilo. There were two common elements
among most of the seizures: First, the chocolates all appeared to
have been made from molds - in several cases, using candy molds, and
in other cases apparently using ice-cube trays (and the seizure in
Virginia was received in an ice-cube tray). In addition, in several
cases, the chocolates were wrapped in colored foil.

These reports
are the first seen by the Office of Forensic Sciences. As noted
above, however, the NDIC report indicates that similar exhibits were
seized in the Vail, Colorado area as long as two years ago, and
furthermore refers to additional seizures made in Colorado, Georgia,
North Carolina, Oregon, West Virginia, and Wisconsin since the
initial seizure in Vail. The NDIC brief also indicates that the
source may be "psilocybin mushroom cultivators in Oregon and
Washington who transport the drug via package delivery services",
and reported the seizures of over 250 pounds of material in nine
incidents by an airport interdiction team in Portland, Oregon. The
above referenced report from the Oregon State Police Forensic
Laboratory in Portland confirmed five such seizures since October
2002 (probably included in the NDIC total).

The first
report of these chocolates (from North Ridgefield, Ohio) in
Microgram Bulletin was reported in the May 2003 issue. The other
three referenced seizures (or sets of seizures) are reported below.
The above referenced intelligence brief from the Narcotics Digest
Weekly is also reproduced below.

RESPONSES
REQUESTED: The widespread appearances, seizure amounts, and
similarities of preparation (candy molds or ice cube trays) and
sales packaging (wrapping in colored foil), suggest the possibility
of a common source (or a loose confederation of sources) and a
nationwide distribution network. The DEA Dangerous Drugs Strategic
Intelligence Unit (NTSG) and the National Drug Intelligence Center (NDIC)
are both interested in this issue. Subscribers are asked to forward
details to NTSG by FAX to 202/307-7916, Attn: J. Hines; and to NDIC
by email to < ronald.strong2@usdoj.gov >.

* * * * *

IN PORTLAND, OREGON

Photo 1

Photo 2

Photo 3

Photo 4

[Summary Report] Beginning in October 2002, the Oregon State Police
Forensic Lab in Portland, Oregon received four separate submissions
of chocolate candies containing ground psilocybin mushrooms from the
Portland Airport Interagency Narcotics Team (PAINT). The candies
were molded into various shapes, including eggs, butterflies, bugs,
Halloween-theme designs, and Reese's-type cups, and arrived wrapped
in metallic foils of assorted colors (see Photos 1
- 2). In all four cases, the concoctions were
being shipped via Federal Express to locations nationwide. In the
largest case, the total net weight of the concoctions exceeded 11
kilograms. A later submission contained nearly 5 kilograms of finely
ground mushroom material (see Photo 3), and
also included the food processor used for grinding the mushrooms.

Under
magnification, grey flakes were visible throughout the chocolate
matrix on all exhibits. Samples were analyzed as follows: The
concoctions were crushed, soaked in dilute sulfuric acid, and washed
with chloroform (to remove some of the fatty components). The acidic
layer was isolated, basified with aqueous NaOH to pH 10, and
extracted with chloroform. Analysis of the extract by GC/MS
indicated caffeine (from the chocolate) and confirmed psilocin. UV
spectrophotometry on the final chloroform extract displayed a broad
absorption in the region consistent with psilocin/psilocybin, but it
was too similar to the UV from a blank chocolate extract to be
considered conclusive. A second analysis was conducted by
particle-picking specks of the mushroom material from the
concoctions (see Photo 4), adding fresh
Weber's color test reagent to them, and noting a color change from
red to blue upon addition of a drop of concentrated HCl (positive
for psilocin). Quantitation was not performed on any of the
exhibits.

[Editor's
Notes: According to the submitter, the relative percentage of
mushrooms varied significantly between seizures; this indicates poor
"quality control" and the potential for overdosing. Additionally,
the submitter indicated that a subsequent (fifth) case was seized
from a UPS package; this confirms that any parcel delivery service
may be utilized for shipment. The latter case was handled by the
Portland Police Department (no further information).]

* * * * *

IN SOUTH KINGSTOWN, RHODE ISLAND

The Drug
Chemistry Section of the Rhode Island State Forensic Laboratory
(Providence, Rhode Island) recently received a submission of two
pieces of chocolate "candy" reported to contain psilocin (See
Photos 5 and 6). The
exhibits were seized in South Kingstown by the South Kingstown
Police Department from an individual who was trying to sell them to
students at a local public school. The chocolates weighed 16 grams
each, and were individually wrapped in colored foil (see upper right
quadrant of Photo 5). After cutting the pieces
in half, visual inspection confirmed that small pieces of (presumed)
mushroom pieces were mixed into the chocolate (see
Photo 6). The mixtures were otherwise homogenous, suggesting
that the mushroom pieces had been mixed with hot, liquified
chocolate, and the resulting concoction allowed to harden in some
type of mold (possibly an ice cube tray). Analysis of a 6% acetic
acid/chloroform extract by GC/MS and UV confirmed psilocin (quantitation
was not performed). This is the first time the laboratory has
received a submission of this type.

Photo 5

Photo 6

* * * * *

IN RICHMOND, VIRGINIA

Photo 7

The DEA Mid-Atlantic Laboratory (Largo, Maryland) recently received
an unusual exhibit consisting of one 14-section plastic ice cube
tray with each compartment containing a cube of hardened mixture of
chocolate and plant material, suspected containing psilocybin
mushrooms (see Photo 7). The exhibit (total
net mass 354.2 grams) was seized from a residence in Richmond,
Virginia by agents from the DEA Richmond District Office, and was
ancillary to an MDMA seizure. Analysis by GC/MS confirmed psilocin (quantitation
was not performed). The exhibit was unusual in that the relative
percentage of mushroom material to chocolate was quite high, varying
between 10 and 20 percent by volume, and the mushrooms were also
"sandwiched" between two layers of chocolate, not evenly
distributed. In addition, the chocolate was a much lighter color
than "normal" chocolate (see Photo); it was
unclear whether this was due to the method of preparation, or if a
lighter colored variety of chocolate was used. This was the first
submission of a chocolate/psilocybin mushroom concoction to the
Mid-Atlantic Laboratory.

[Editor's
Notes: According to the Case Agent, the perpetrators in this case
were making the concoction themselves, not receiving it from an
outside source. The mushrooms were allegedly provided by a relative
in New England.]

* * * * *

IN VAIL, COLORADO

From the April 29, 2003 issue of the
Narcotics Digest Weekly
(Reprinted with Permission)

Colorado:
The Vail Police Department reports that local independent
dealers increasingly are distributing chocolate-coated psilocybin
mushrooms wrapped in multicolored foil--a practice that was first
reported in the Vail area approximately 18 to 24 months ago. The
chocolate-coated psilocybin mushrooms typically are distributed at
area concerts and private parties for $10 per 1-inch cube. Police
officials believe that distributors are supplied by psilocybin
mushroom cultivators in Oregon and Washington who transport the drug
via package delivery services.

NDIC
Comment: Coating psilocybin mushrooms in chocolate provides
traffickers with an effective method of concealment and enables
abusers to ingest the drug in public settings. Law enforcement
reporting indicates that chocolate-coated psilocybin mushroom
distribution has recently increased in several areas of the United
States, including Colorado, Georgia, North Carolina, Oregon, West
Virginia, and Wisconsin. Moreover, law enforcement reporting
indicates that Portland, Oregon, is one of the primary source areas
for chocolate-coated psilocybin mushrooms. From September 2002 to
April 2003, law enforcement authorities with the Portland Police
Bureau, DEA, and the Portland Airport Interagency Narcotics Team
(PAINT) seized over 250 pounds of chocolate-coated psilocybin
mushrooms in nine incidents. The psilocybin mushrooms were being
transported from Oregon to markets throughout the United States via
package delivery services.

* * * * *

- INTELLIGENCE BRIEF-

VERY LARGE ECSTASY LABORATORY SEIZED
IN BANGOR, PENNSYLVANIA

In early December 2002, agents from the Pennsylvania Office of
Attorney General, Bureau of Narcotics Investigation (BNI), seized a
very large MDMA production laboratory in Bangor, Pennsylvania
(located about 90 miles north of Philadelphia). A supply and storage
warehouse in nearby Roseto was also seized; this latter facility was
acting as a front company to purchase precursor and essential
chemicals - the nominal purpose of which was to create flavoring
ingredients for fruit juices. Unusually, the laboratory was located
within a 30,000 gallon steel drum that had been mostly buried
underneath the very long driveway of the operator's rather isolated
residence, and was further obscured from view and camouflaged with
large boulders (see Photos 8 and
9).

Photo 8

Photo 9

Safrole and sassafras oil were both recovered. Based on the various
chemicals found at the site, the operator was apparently converting
safrole to isosafrole, oxidizing isosafrole to the corresponding
phenylacetone, and using methylamine (probably produced from
acetamide) to produce MDMA via an aluminum amalgam reduction. A
tableting press was also recovered (see Photo 10).
Tablets purchased during the investigation and recovered at the
laboratory site (approximately 4,000) weighed 290 - 295 milligrams
each, and were brownish-white, plain (no logo), and unscored (see
Photo 11; closeup photo not available).
Analysis confirmed MDMA (quantitation not reported). Agents on-site
estimated that the laboratory had been in operation for at least two
years, and was capable of producing more than one million Ecstasy
tablets per year - making it likely the largest MDMA laboratory ever
seized in the eastern United States. The tablets were distributed
throughout the (local) Lehigh Valley and also in several nearby
states.

Also submitted as a result of an (unrelated) vehicle stop was a
FedEx box containing three exhibits. The first was a bag of white
crystalline material, net mass 672.7 grams, suspected "Ice"
methamphetamine (photo not available). Analysis by GC/MSD and by
chemical derivatization confirmed methamphetamine (not quantitated).
The second was 48 boxes of 10 mL injectable vials, each labelled "Ketaphorte
1000 mg Anasthesia Injectable, Cosulte al Medico Veternario,
ketamina base 100 mg" (photo not available). Analysis by GC/MSD and
UV confirmed ketamine (not quantitated). The third was a red tablet
with a "TP" logo, suspected Ecstasy (photo not available; net mass
not reported). Analysis by GC/MSD and chemical derivatization
indicated a mixture of methamphetamine, MDMA, and caffeine. This
second set of seizures was notable because the "Ice" methamphetamine
exhibit was the largest ever submitted to the Broward Sheriff's
Office Crime Laboratory.

Photo
13

Photo
14

* * * * *

- INTELLIGENCE BRIEF -

MDMA TABLETS WITH A "DOVE" LOGO IN REDDING,
CALIFORNIA

Photo
15

The California Department of Justice, Bureau of Forensic Services,
Redding Criminalistics Laboratory (Redding, California -
approximately 150 miles north of Sacramento) recently received six
light green pills (approximately 7 mm x 4-5 mm) with a dove logo,
submitted as an unknown (see Photo 15). The
pills were obtained in Redding by the Redding Police Department, as
a result of a traffic stop; two baggies of cocaine were also seized.
Analysis of the tablets by color testing and GC/MS confirmed MDMA
(not quantitated). A tablet similar to this submission was found on
the Internet (www.dancesafe.org/labtesting/), but this was the first
time these type of pills have been submitted to the Redding
Laboratory.

* * * * *

- INTELLIGENCE BRIEF -

TABLETS CONTAINING MIXED PIPERAZINES IN ALGONA,
IOWA

Photo
16

The Iowa Division of Criminal Investigation Criminalistics
Laboratory (Des Moines, Iowa) recently received three pink tablets,
composition unknown, total net mass 450 milligrams. The tablets
measured 10 mm x 4 mm and had an indistinct logo (see
Photo 16). The exhibits were seized in Algona
by the Algona Police Department as a result of a vehicle stop to
serve an arrest warrant for methamphetamine manufacture. Analysis by
TLC and GC/MS indicated a mixture of benzylpiperazine (BZP),
trifluromethylphenylpiperazine (TFMPP), and
ortho-methoxyphenylpiperazine (OMPP) (quantitation not performed,
but all three compounds showed strong peaks in the GC/MS run). The
tablets appear to be quite similar in color and composition to mixed
piperazine tablets previously reported in Microgram Bulletin. This
is the first encounter of these federally controlled Schedule I
substances in Iowa. BZP, TFMPP, and OMPP are not yet scheduled in
Iowa; however, it is anticipated they will become Schedule I (Iowa)
by next year.

* * * * *

- INTELLIGENCE BRIEF -

COCAINE IN PLASTIC PLANTAINS IN STATEN ISLAND,
NEW YORK

The DEA Northeast Laboratory (New York, New York) recently received
an unusual submission of green plastic plantains containing
suspected cocaine (see Photo 17). The
plantains were seized by U.S. Coast Guard and the DEA-NY Task Force
from a shipping container that was destined for New York City. Each
plantain measured approximated 12.5 x 2.5 inches, and contained a
cylinder of compressed powder within a balloon (see
Photo 18). Analysis by GC/MS, FTIR, and GC
confirmed 75 percent cocaine hydrochloride. In all, 702 plantains
contained a total net mass of 90.05 kilograms. Although this
laboratory has analyzed many cocaine samples from variety of
smuggling techniques, this was the first encounter of this
particular method of concealment.

Photo
17

Photo
18

* * * * *

- INTELLIGENCE BRIEF -

"LIQUID HEROIN" IN RUM BOTTLES AT JFK AIRPORT,
NEW YORK

Photo
19

The DEA Northeast Laboratory (New York, New York) recently received
three "Havana Club" rum bottles containing a brown-colored liquid,
that field-testing indicated contained heroin (see
Photo 19). The bottles were seized by U.S.
Customs at JFK International Airport in Queens, New York, from a
passenger arriving from Cali, Colombia. Analysis by GC/MS, FTIR, and
GC confirmed 319 milligrams heroin hydrochloride per milliliter. A
total net mass of 702 grams of heroin hydrochloride was recovered
from about 2.2 liters of liquid (suspected alcohol based, not
further identified). Although this laboratory has analyzed many
liquid cocaine samples, liquid heroin is very unusual. However,
field intelligence suggests that this method of smuggling heroin may
be encountered more frequently in the near future.

* * * * *

- INTELLIGENCE BRIEF -

COCAINE BRICK PRESS SEIZED IN MIAMI, FLORIDA

Photo
20

The DEA Southeast Laboratory (Miami, Florida) recently received a
cocaine brick mold contaminated with white powder, plus two
additional exhibits of white powder, one of which was recovered from
the mold, suspected to be cocaine or a cocaine adulterant/diluent.
The exhibit was seized from a private residence in Miami by
personnel from the DEA Miami Field Division. A hydraulic press was
also found at the residence, but was not submitted to the
laboratory. At the time of seizure, the powder was being compressed
into a brick. The mold inside dimensions were approximately 8 x 6 x
3 inches (see Photo 20). Analysis of the
powder being pressed in the mold (total net mass 665.9 grams) by
GC/FID and GC/MS confirmed 15 percent cocaine hydrochloride, cut
with tetracaine and caffeine. Analysis of the second powder exhibit
(total net mass 277.0 grams) identified it to be a mixture of
tetracaine and caffeine. This was the first seizure of a cocaine
brick mold to the Southeast Laboratory.

[Editor's Notes: According to the analyst, the evidence and related
intelligence confirmed that the perpetrators were cutting higher
purity cocaine and repressing it for sale. This would mimic
analogous cocaine and heroin "pelleting" operations previously
reported in Microgram Bulletin.]

* * * * *

- INTELLIGENCE BRIEF -

RED "CRACK" IN NAPOLEONVILLE, LOUISIANA

Photo
21

The DEA South Central Laboratory (Dallas, Texas) recently received a
submission of eight plastic, knotted baggies, each containing a red,
hard chunky material, suspected cocaine base, total net mass 48.1
grams (see Photo 21). The exhibit was
purchased by DEA New Orleans in Napoleanville, Lousisiana (south of
Baton Rouge and west of New Orleans). Analysis by color testing,
FTIR, ATR, GC/MS, and HPLC confirmed 54 percent cocaine base. The
red color was apparently due to food coloring or a similar dye (not
further investigated). Of note, the red color gave some interference
with typical color tests. Cocaine base is routinely analyzed by the
South Central Laboratory, but it is usually seen as an off-white or
beige color.

[Editor's Note: According to the Case Agent, the red coloring was
not a marketing ploy, but rather an effort to pass the cocaine off
as candy or cookie parts in case of approach by law enforcement
personnel.]

* * * * *

- INTELLIGENCE BRIEF -

PSILOCIN/TETRAHYDROCANNABINOL MIXTURE IN VISTA,
CALIFORNIA

The DEA Southwest Laboratory (San Diego, California) recently
received an unusual sample consisting of a ziploc bag containing a
brown/gray substance suspected to be psilocin, net mass 11.5 grams
(photo not available). The exhibit was seized by DEA personnel in
Vista, California. After extraction from a sodium bicarbonate
triturate into ether, however, analysis by GC/MS indicated not just
psilocin but rather a mixture of psilocin and
delta-9-tetrahydrocannabinol (THC), cannabinol, and cannabidiol.
Further investigation using a microscope (under 10x magnification)
determined that no marijuana was present; however, the microscopic
examination revealed that vermiculite was mixed into the sample.
Vermiculite is an absorptive substance used as a packing material
and also as a support media for growing plants. It is speculated
that the vermiculite present in the sample had been previously used
in a marijuana grow operation, and thereby absorbed the cannabinoids
that were identified in the extract. Of note, the other psilocin
samples submitted in this case contained no vermiculite or
cannabinoids.

[This
Information Bulletin is an overview of the distribution and abuse of
Salvia Divinorum, an herb that contains the hallucinogen Salvinorin
A. It includes a discussion of the drug's background, abuse,
availability, federal legislation, and outlook.]

* * * * *

The distribution and abuse of Salvia divinorum or S. divinorum, a
plant that contains the hallucinogen Salvinorin A, are becoming an
increasing concern for law enforcement officials in the Northeast,
Midwest, and Pacific regions of the country. Neither Salvia
divinorum nor Salvinorin A is federally regulated in the United
States or controlled in any other country except Australia, which
adopted controlling legislation in 2002. Thus, Salvia divinorum is
openly distributed via Internet sites and "head shops" located in
California, Hawaii, Missouri, New York, Washington, and Wisconsin.

Background

Salvia divinorum (pronounced SAL-vee-ah dee-vin-OR-um)--frequently
referred to as "Ska Maria Pastora" and "Diviner's Sage"--is a
perennial herb in the mint family that resembles sage. The plant is
native to certain areas of the Sierra Mazateca region of Oaxaca,
Mexico, but can be grown in any humid, semitropical climate as well
as indoors. Within the United States, the plant primarily is
cultivated in California and Hawaii. It grows in large clusters and
reaches over 3 feet in height.

Salvinorin A is the active component of Salvia divinorum. Other
plants with similar properties include Cannabis sativa, which
contains tetrahydrocannabinol, the primary psychoactive compound in
marijuana and Artemisia absinthium, known as wormwood and used to
make absinthe. At this time there is no accepted medical use for
Salvia divinorum; however, Mazatec Indians in Mexico use the plant
in traditional healing ceremonies and to induce visions. The manner
in which Salvia divinorum interacts with the brain to produce its
hallucinogenic effect remains unclear.

Abuse

Abusers ingest Salvia divinorum using various methods of
administration. Like tobacco, Salvia divinorum can be smoked or
chewed. It also can be brewed and ingested as a tea. When converted
into a liquid extract, Salvia divinorum also can be vaporized and
inhaled. Immediately after ingesting the drug, abusers typically
experience vivid hallucinations--including out-of-body experiences,
sensations of traveling through time and space, and feelings of
merging with inanimate objects. Some abusers experience intense
synesthesia, an effect that causes the abusers' senses to become
confused. For example, abusers may describe hearing colors or
smelling sounds. The hallucinogenic effects generally last 1 hour or
less unlike other hallucinogens like LSD and PCP. High doses of the
drug can cause unconsciousness and short-term memory loss.

The long-term effects of Salvia divinorum abuse are unknown, as
medical studies undertaken to examine the drug's physiological
effects have focused only on short-term effects. However,
information provided by abusers indicates that the negative
long-term effects of Salvia divinorum may be similar to those
produced by other hallucinogens such as LSD (lysergic acid
diethylamide) including depression and schizophrenia. Some abusers
also indicate that long-term abuse can cause hallucinogen persisting
perception disorder, or "flashbacks". Numerous individuals report
experiencing negative effects during their first experience with
Salvia divinorum and indicate that they would not use it a second
time. Some others report that the drug caused them to become
introverted and sometimes unable to communicate clearly.

National surveys conducted to estimate rates of drug abuse do not
include questions regarding abuse of Salvia divinorum. Thus, current
levels of abuse are difficult to determine. Most likely, the abuser
population is limited and primarily consists of young adults and
adolescents who frequent "head shops" or have been influenced by
Internet sites promoting the drug. The percentage of first-time
users who become regular abusers of the substance also is difficult
to determine; however, one Internet distributor indicated that only
1 in 10 customers places a repeat order for the drug.

Adolescent Abuse of Salvia Divinorum in St.
Peters, Missouri

Law
enforcement officials in St. Peters, Missouri, indicate that
Salvia divinorum abuse by young people in that area is extremely
high. Abuse levels among youths are so high that St. Peters
became the first community to enact a local ordinance designed
to regulate the distribution of Salvia divinorum. The
ordinance--enacted in January 2003--makes it unlawful "for any
person to engage in the sale or distribution of Salvia divinorum
a/k/a Salvinorin A, or any variation thereof, to an individual
who is seventeen years of age or younger". The ordinance does
not apply to the distribution of Salvia divinorum by a family
member on private property. Violations of the city ordinance are
punishable by a $25 fine for the first offense, $100 for the
second offense, and $250 for the third and subsequent offenses.
According to the city's Board of Aldermen, enactment of the
ordinance was necessary due to high rates of abuse by
adolescents and concerns that the herb poses a threat to the
health, safety, and welfare of residents of St. Peters.

Availability

Salvia divinorum most often is distributed via the Internet and at
some "head shops" in California, Hawaii, Missouri, New York,
Washington, and Wisconsin. Prices for Salvia divinorum vary widely
but are generally higher for plants grown in Hawaii and Sierra
Mazateca (Central Mexico). An ounce of Salvia divinorum leaves sells
for $15 to $120 while Salvia divinorum plants generally sell for $20
to $45 each. Liquid extract of Salvia divinorum--produced by
crushing the leaves of the plants and using solvents to extract
Salvinorin A--sells for $110 to $300 per ounce. Purchased primarily
via the Internet, Salvia divinorum is transported to customers via
package delivery services.

The
production, distribution, and abuse of Salvia divinorum or
Salvinorin A currently are not federally regulated as the drug is
not listed under Title 21 U.S. Code §812 of the Controlled
Substances Act. However, HR 5607 (the Hallucinogen Control Act of
2002)--introduced in Congress on October 10, 2002--contains
provisions to regulate Salvia divinorum and Salvinorin A. This bill
was not acted upon when the 107th Congress adjourned, but is
expected to be reintroduced during the current session. In response
to the introduction of legislation on Salvia divinorum, a group has
formed to lobby Congress to fight any attempts to regulate the use
or availability of Salvia divinorum and Salvinorin A in the United
States.

Outlook

Increasing
numbers of young adults and adolescents most likely will experiment
with Salvia divinorum as the drug currently is unregulated and
readily available via the Internet and "head shops". Salvia
divinorum most likely will not become widely abused at social events
such as raves and dance parties. The drug often causes some
individuals to become introverted, and abusers at such events tend
to seek drugs that enhance social interaction such as MDMA
(3,4-methylenedioxymethamphetamine, also known as ecstasy). Proposed
federal legislation to control Salvia divinorum and Salvinorin A may
impact its availability, as distributors may be hesitant to sell the
drug openly.

SUMMARY:
The
Drug Enforcement Administration (DEA) is revising the wording of the
DEA regulations to clarify that the listing of "Tetrahydrocannabinols"
(THC) in schedule I of the Controlled Substances Act (CSA) and DEA
regulations refers to both natural and synthetic THC.

What Does
This Rule Accomplish and by What Authority Is It Being Issued?

This final
rule clarifies that, under the CSA and DEA regulations, the listing
of "Tetrahydrocannabinols" in schedule I refers to both natural and
synthetic THC.
This rule is being issued pursuant to 21 U.S.C. 811, 812, and
871(b). Sections 811 and 812 authorize the Attorney General to
establish the schedules in accordance with the CSA and to publish
amendments to the schedules in the Code of Federal Regulations, part
1308 of title 21. Section 871(b) authorizes the Attorney General to
promulgate and enforce any rules, regulations, and procedures which
he may deem necessary and appropriate for the efficient enforcement
of his functions under the CSA. These functions vested in the
Attorney General by the CSA have been delegated to the Administrator
and Deputy Administrator of DEA. 21 U.S.C. 871(a); 28 CFR 0.100(b)
and 0.104, appendix to subpart R, sec. 12.

Why Is
There A Need To Clarify The Meaning of "Tetrahydrocannabinols"?

As DEA
explained in its October 9, 2001 interpretive rule (66 FR 51530;
hereafter "interpretive rule"), it is DEA's interpretation of the
plain language of the CSA and DEA regulations that the listing of "Tetrahydrocannabinols"
in schedule I refers to both natural and synthetic THC. Despite the
wording of the statute, some members of the public were under the
impression (prior to the publication of the interpretive rule) that
the listing of "Tetrahydrocannabinols" in schedule I includes only
synthetic THC--not natural THC. To eliminate any uncertainty, DEA is
hereby revising the wording of its regulations to refer expressly to
both natural and synthetic THC.

Why Should
Natural THC Be Considered a Controlled Substance?

There are
several reasons why natural THC should be considered a controlled
substance. First, as explained in the interpretive rule, it is
evident from the plain language of the CSA that Congress intended
all THC--natural or synthetic--to be a schedule I controlled
substance. Congress did so by listing "Tetrahydrocannabinols" in
schedule I of the CSA--without limiting "Tetrahydrocannabinols" to
either natural or synthetic form. 21 U.S.C. 812(c), Schedule I(c)(17).
The basic dictionary definition of the word "tetrahydrocannabinols"
refers collectively to a category of chemicals--regardless of
whether such chemicals occur in nature or are synthesized in the
laboratory.\1\

Second, every
molecule of THC has identical physical and chemical properties and
produces identical psychoactive effects, regardless of whether it
was formed in nature or by laboratory synthesis.\2\ Likewise, a
product that contains THC in a given formulation will cause the same
reaction to the human who ingests it regardless of whether the THC
is natural or synthetic. Indeed, some researchers are currently
investigating the possibility of using natural THC (extracted from
cannabis plants) in drug products.\3\

[\2\ In this
context, "every molecule of THC" refers to every molecule of the
same isomer of THC. For example, all molecules of \9\-(trans)-THC
are identical, regardless of whether they are natural or synthetic.
It should also be noted that "Tetrahydrocannabinols" refers to a
class of substances which includes \9\-(trans)-THC, its isomers, and
other related substances. Collectively, this class will be referred
to in this document as "THC," unless otherwise indicated.

\3\ At
present, Marinol[reg] is the only THC-containing drug product that
has been approved for marketing by FDA. Marinol[reg] contains
synthetic dronabinol (an isomer of THC) in sesame oil and
encapsulated in soft gelatin capsules. This product has been
approved for the treatment of nausea and vomiting associated with
cancer chemotherapy as well as the treatment of anorexia associated
with weight loss in patients with AIDS. See 64 FR 35928 (1999) (DEA
final order transferring Marinol[reg] from schedule II to schedule
III).]

Third,
regardless of its source, THC meets the criteria for classification
in schedule I of the CSA. It is an hallucinogenic substance with a
high potential for abuse and no currently accepted medical use.\4\
See 21 U.S.C. 812(b)(1). Thus, for purposes of CSA scheduling, there
is no basis for distinguishing natural THC from synthetic THC.

[\4\ There
are no FDA-approved drug products that consist solely of THC.
However, as stated in the preceding footnote, the FDA has approved a
drug product (Marinol[reg]), which contains synthetic THC with other
ingredients in a specified product formulation.]

Fourth, to
ignore the foregoing considerations and to treat natural THC as a
noncontrolled substance would provide a loophole in the law that
might be exploited by drug traffickers. If natural THC were a
noncontrolled substance, those portions of the cannabis plant that
are excluded from the CSA definition of marijuana (the stalks and
sterilized seeds of the plant) would be legal, noncontrolled
substances--regardless of their THC content. As a result, it would
be legal to import into the United States, and to possess, unlimited
quantities of cannabis stalks and sterilized seeds--again,
regardless of their THC content. Anyone could then obtain this raw
cannabis plant material to produce an extract of THC--all without
legal consequence. This would give drug traffickers an essentially
limitless supply of raw plant material from which they could produce
large quantities of a highly potent extract that would be considered
a noncontrolled substance and, therefore, entirely beyond the reach
of law enforcement. To provide such a safe harbor to drug
traffickers would be plainly at odds with the purpose and structure
of the CSA.\5\

[\5\ As one
United States Court of Appeals has stated, "a reading of the [CSA]
and its legislative history makes it apparent that Congress, in
legislating against drug use, intended to encompass every act and
activity which could lead to proliferation of drug traffic. Nothing
in the statute indicates any congressional intent to limit the reach
of this legislation, which is described in its title as
‘Comprehensive.'" United States v. Everett, 700 F.2d 900, 907 (3d
Cir. 1983) (internal citations omitted).]

Does This
Rule Change the Legal Status of "Hemp" Products?

This rule
does not change the legal status of so-called "hemp" products
(products made from portions of the cannabis plant that are excluded
from the CSA definition of marijuana). Rather, this rule clarifies
provisions of the law and regulations that have been in effect since
1971. For the reasons provided in the interpretive rule, it is DEA's
view that the CSA and DEA regulations have always (since their
enactment more than 30 years ago) declared any product that contains
any amount of tetrahydrocannabinols to be a schedule I controlled
substance. This interpretation holds regardless of whether the
product in question is made from "hemp" or any other material.
Nor does this rule add to, or subtract from, the exemptions issued
by DEA in the October 9, 2001 interim rule. Every type of "hemp"
product that was exempted from control under that interim rule will
remain exempted following the finalization of this rule. Thus, given
DEA's interpretation of current law (expressed in the interpretive
rule), this rule does not change the legal status of any "hemp"
product.

What Is
the Difference Between This Final Rule and the Previously-Issued
Interpretive Rule?

This final
rule is a legislative rule. It is important to understand the
difference between a legislative rule and an interpretive rule, such
as the interpretive rule on THC that DEA issued on October 9, 2001.
The following is a brief explanation of the difference between
legislative rules and interpretive rules.
Under the Administrative Procedure Act (APA), agencies may issue
interpretive rules to advise the public of how the agency interprets
a particular provision of a statute or regulation which the agency
administers.\6\ By definition, interpretive rules are simply the
agency's announcement of how it interprets existing law.
Interpretive rules are not new laws and are not binding on the
courts. Even though courts often defer to an agency's interpretive
rule, they are always free to choose otherwise.

[\6\ See
Shalala v. Guernsey Memorial Hosp., 514 U.S. 87, 99 (1995).]

Legislative
rules, on the other hand, have the full force of law and are binding
on all persons, and on the courts, to the same extent as a
congressional statute.\7\ Because of this crucial difference, the
APA requires agencies to engage in notice-and-comment proceedings
before a legislative rule takes effect.\8\ By the same reasoning,
since interpretive rules do not have the full force of law and are
not binding on the courts, the APA expressly allows agencies to
issue interpretive rules without engaging in notice-and-comment. 5
U.S.C. 553(b)(A), (d)(2).

\8\ Syncor
Int'l Corp. v. Shalala, 127 F.3d 90, 95 (D.C. Cir. 1997) ("it is
because the agency is engaged in lawmaking [when it issues a
legislative rule] that the APA requires it to comply with notice and
comment").]

Consistent
with these APA principles, DEA published the interpretive rule in
October 2001 without notice and comment, whereas the legislative
rule that is being finalized in this document has gone through
notice and comment. As a result, this final rule will have the full
force of law and be binding on the courts--just as with all the
other DEA regulations that have gone through notice and comment.\9\
In contrast, the interpretive rule was not binding on the courts.
The practical effect of this distinction can be seen by considering
the following hypothetical scenarios. If, prior to the publication
of this final rule, a federal prosecution was commenced based solely
on DEA's interpretive rule, the presiding court would have been free
to choose between applying DEA's interpretation or its own
interpretation of the law. But once this rule becomes final, if a
person were to refuse to abide by the regulation and a federal
prosecution were commenced, the court would be required to apply the
new regulation.\10\

[\9\ The DEA
regulations are published in Title 21 of the Code of Federal
Regulations, Part 1300.
\10\ Legislative regulations are controlling on the courts unless
they are "arbitrary, capricious, or manifestly contrary to the
statute." Chevron, U.S.A. v. Natural Resources Defense Council, 467
U.S. 837, 844 (1984).]

Comments
That DEA Received in Response to the Proposed Rule

Following
publication of the proposed rule, DEA received comments from
thousands of individuals and groups. The comments were in the form
of original letters, form letters, petitions, and a cookbook. Those
who submitted comments included companies that manufacture and
distribute various "hemp" products, associations that represent such
manufacturers and distributors, domestic and Canadian government
officials, and individuals. These commenters expressed criticisms on
a variety of issues. In accordance with the APA, DEA carefully
considered all of the comments it received.

Most of the
comments that DEA received relate to both the proposed rule (DEA
205; 66 FR 51535) and the interim rule (DEA 206; 66 FR 51539), which
were published together (along with the interpretive rule) in the
October 9, 2001 Federal Register. Those comments that pertain
primarily to DEA 205 are addressed in this final rule. Those
comments that pertain primarily to DEA 206 are addressed in the
final DEA 206 rule, which appears in a separate Federal Register
document that immediately follows this document. Both DEA 205 and
DEA 206 contain a summary of the pertinent comments, along with an
explanation of how DEA considered them in deciding to finalize the
rules.

The number of
individuals and groups that participated in the comment process far
exceeded the number of different issues raised. Many of the comments
were similar to one another, partly because many persons submitted
form letters or signed petitions written by groups which themselves
submitted lengthy comments. In this document, together with the
final rule finalizing the DEA 206 interim rule, DEA has addressed
the major issues raised by the commenters. Some of these issues have
already been addressed in the text that precedes this section. The
remaining issues are addressed below and in the DEA 206 final rule.

Comments
Expressing Legal Disagreement With the Proposed Rule

Many
commenters disagreed with DEA's legal interpretation of those
provisions of the CSA and DEA regulations that are relevant to the
proposed rule. Specifically, these commenters disagreed with DEA's
view that, under the plain language of the CSA, "any material,
compound, mixture, or preparation, which contains any quantity of *
* * Tetrahydrocannabinols (THC)" is a schedule I controlled
substance. 21 U.S.C. 812(c), schedule I(c)(17); 21 CFR
1308.11(d)(27). These commenters asserted that THC content is
irrelevant when it comes to products made from portions of the
cannabis plant that are excluded from the definition of marijuana.
According to these commenters, DEA should allow the CSA definition
of marijuana to dictate which portions of the cannabis plant are
controlled substances. DEA addressed this issue in detail in the
legal analysis contained in the interpretive rule. Nonetheless, many
commenters asserted that their point of view is the correct reading
of the law and should be substituted for that of DEA. DEA reexamined
this issue in view of the comments. While recognizing that many
proponents of "hemp" products are steadfast in their view that
natural THC content is irrelevant in deciding what is a controlled
substance, DEA continues to believe that its interpretation follows
directly from the plain language of the CSA and the DEA regulations
and is consistent with the legislative history of the statute and
regulations. Moreover, DEA believes that the analysis contained in
the interpretive rule refutes all of the contrary legal arguments
expressed in the comments. As the agency responsible for
administering the CSA, it is DEA's obligation to ensure that the
regulations clearly reflect what the agency believes are the purpose
and intent of the Act.

Comments
as to Whether This Rule Constitutes a Rescheduling Action

Some
commenters expressed the view that this rule is a rescheduling
action within the meaning of 21 U.S.C. 811 and that DEA should have
gone through the procedures set forth in that section prior to
issuing this rule.\11\ These comments appear to be based on a
misunderstanding of the nature of the procedures under section 811.
By its express terms, section 811 applies only where DEA seeks to
add a substance to a schedule or remove one from a schedule. For
example, if DEA were seeking to move a controlled substance from
schedule II to schedule III, the agency would be required to follow
the procedures set forth in section 811. The final rule being
published today, however, does not change the schedule of THC or any
other controlled substance. To the contrary, when this final rule
becomes effective, on April 21, 2003, THC will remain in the same
schedule in which it has been since the enactment of the CSA in
1970: Schedule I.

[\11\ Under
21 U.S.C. 811, to change the schedule of a controlled substance, DEA
must first request from the Secretary of Health and Human Services a
scientific and medical evaluation and scheduling recommendation and
follow additional procedures set forth in section 811. However, as
discussed above, section 811 is inapplicable where, as in this final
rule, DEA is not changing the schedule of a controlled substance.]

Nor would
engaging in the rescheduling procedures set forth in section 811 be
consistent with the purpose of this rule. Section 811 sets forth the
procedures to determine whether a particular substance meets the
criteria for placement in a particular schedule. The purpose of this
rule is not to determine whether THC meets the criteria for
classification in schedule I; rather, this rule serves to clarify
that the longstanding placement of THC in schedule I includes both
natural and synthetic THC. There is no question about whether THC
meets the criteria for placement in schedule I.\12\ Even those
commenters who suggested that this rule should be issued under
section 811 do not dispute that all THC (natural or synthetic) meets
the criteria for placement in schedule I. As discussed above, the
chemical THC has the identical physical and chemical properties, and
produces the same psychoactive effects, regardless of whether it is
natural or synthetic. For these reasons, section 811 is inapplicable
to this rule.

[\12\ The
criteria for placement in schedule I are: "no currently accepted
medical use in treatment in the United States," "a lack of accepted
safety for use * * * under medical supervision," and "a high
potential for abuse." 21 U.S.C. 812(b)(1).]

Comments
Regarding Poppy Seeds

Some of the
commenters asserted that DEA should not take literally the plain
language of the CSA: that "any material, compound, mixture, or
preparation, which contains any quantity of * * *
Tetrahydrocannabinols [THC]" is a schedule I controlled substance.
To read this provision literally, some commenters said, would mean
that poppy seeds must be considered controlled substances if they
contain trace amounts of opiates (such as morphine, codeine, or
thebaine). This concern is unfounded because, under the CSA and DEA
regulations, substances that contain opiates are controlled
differently than substances that contain schedule I hallucinogens
(such as THC). It is true that poppy seeds are excluded from the
definition of opium poppy (21 U.S.C. 802(19)) just as sterilized
cannabis seeds are excluded from the definition of marijuana.
However, while it is the case that "any material, compound, mixture,
or preparation, which contains any quantity of" an hallucinogenic
controlled substance is a controlled substance (21 U.S.C. 812(c),
schedule I (c); 21 CFR 1308.11(d)), it is not the case that any
material, compound, mixture, or preparation which contains any
quantity of an opiate is a controlled substance. Rather,
naturally-occurring opiates found in substances of vegetable origin
are subject to control under the CSA only if they are extracted from
the substances of vegetable origin. 21 U.S.C. 812(c), schedule II(a);
21 CFR 1308.12(b)).\13\

[\13\ Plant
materials that are the source of narcotics, such as opium poppy,
poppy straw, and opium, are specifically listed in schedule II.
However, as stated above, the listing of opium poppy does not
include poppy seeds, since the seeds are excluded from the
definition of opium poppy.]

Comments
Regarding the Single Convention on Narcotic Drugs

Several
commenters asserted that the proposed rule is impermissible in view
of a certain provision of the Single Convention on Narcotic Drugs,
1961 ("Single Convention"). The Single Convention, which the United
States ratified in 1967, was designed to establish effective control
over international and domestic traffic in controlled substances,
and parties to the Convention are required to implement certain
minimum measures. Article 28 of the Single Convention imposes on
parties certain restrictions on the cultivation of the cannabis
plant. However, paragraph 2 of Article 28 states that the Single
Convention does not apply "to the cultivation of the cannabis plant
exclusively for industrial purposes (fibre [sic] and seed) or
horticultural purposes." Several commenters asserted that this
provision means that the United States is prohibited from imposing
any restrictions on "hemp." This assertion is incorrect.

The Single
Convention sets minimum standards of drug control measures that the
parties must apply--not maximum measures. Parties are free to impose
whatever additional measures they believe are necessary to prevent
the misuse, and illicit traffic in, controlled substances. Indeed,
various provisions of the CSA go beyond the minimum measures
required by the Single Convention. Congress's decision under the CSA
to control anything that contains "any quantity" of THC is the
decisive factor for purposes of this rule, regardless of whether a
less restrictive rule would be permissible under the Single
Convention.\14\

[\14\ To
fully address the distinctions between the control of cannabis under
the Single Convention and the control of marijuana and THC under CSA
would require a lengthy discussion. Such a discussion is unnecessary
here because this rule is based on how THC is controlled under the
CSA. Thus, there is no need to address here whether the reference in
the Single Convention (Article 28, paragraph 2) to cannabis grown
for "industrial" or "horticultural" purposes includes cannabis grown
to make foods or beverages, or whether such reference is limited to
non-human-consumption items such as rope, paper, textiles,
industrial solvents, and birdseed.
A full analysis of the international drug control treaties would
also require discussion of the Convention on Psychotropic
Substances, 1971 (Psychotropic Convention). THC is a substance
listed in the schedules of the Psychotropic Convention. Accordingly,
the United States, as a party to the Psychotropic Convention, has
certain obligations thereunder with respect to the control of THC.
However, it is unnecessary to examine the scope of those obligations
in this document because Congress stated expressly in United States
domestic law that anything that contains "any quantity" of THC is a
schedule I controlled substance, unless listed in another schedule
or expressly exempted. Adherence to this rule and the corresponding
provisions of the CSA ensures that the United States meets its
obligations under the Psychotropic Convention with respect to THC.]

Comments
Regarding Trade Agreements

Some
commenters expressed the view that the proposed rule violates
certain obligations of the North American Free Trade Agreement
(NAFTA) and the World Trade Organization (WTO) agreements. Many of
these same commenters expressed these assertions to DEA before the
proposed rule was published in October 2001. As a result, both
before and after publication of the proposed rule, DEA sought the
input of the Department of State and other components of the
Executive Branch with the relevant expertise and responsibility for
such matters and concluded that the proposed rule--which simply
clarifies longstanding federal law with respect to schedule I
hallucinogenic controlled substances--does not violate NAFTA or the
WTO agreements.
One of the bases for these treaty claims asserted by commenters is
the contention that the proposed rule provides more favorable
treatment to United States and foreign, non-Canadian investors and
their investments than to Canadian "hemp" investors and their
investments in the United States. In reality, the rule applies to
and treats all "hemp" industry investors and their investments the
same--i.e., regardless of nationality of ownership. No company
(whether Canadian-owned, foreign but non-Canadian-owned, or United
States-owned) can manufacture, distribute or market products used,
or intended for use, for human consumption that contain any amount
of THC. DEA has made no exception to this rule for any United States
company or any foreign company.

Comments
Requesting an Extension of the Comment Period

Some
commenters asked DEA to extend the comment period. DEA did not do so
for the following reasons. In the notice of the proposed rule, DEA
provided a 60-day comment period from the date of the publication in
the Federal Register, which allowed ample time for any
interested persons to express their opinions.
DEA considered all comments that were postmarked within the comment
period, even where the agency did not receive the comments until
several months after the comment period closed.\15\ It is evident
from the number and variety of comments that were submitted, and the
detailed nature of such comments, that a wide range of viewpoints
was expressed to the agency during the comment period. Nearly all of
the types of comments that were submitted during the comment period
were repeated many times over by a number of commenters, which
further indicates that interested parties have had sufficient
opportunity to express their comments.

[\15\ At the
time the comment period closed, postal deliveries to DEA and other
agencies were delayed after the widely-reported incidents of anthrax
being sent through the mail. Because of this, although the proposed
rule indicated that DEA would only consider comments received on or
before December 10, 2001, the agency considered all comments
postmarked by that date, even if they arrived late.]

DEA provided
the public with advance notice of the rules. In the year preceding
the October 9, 2001 publication of the rules, DEA announced twice in
the Federal Register that the agency would be issuing the
proposed rule, along with the interpretive rule and the interim
rule, and described the nature of the rules. See Department of
Justice Unified Agenda, 66 FR 25624 (May 14, 2001), 65 FR 74024
(November 30, 2000). It is evident from the comments submitted on
the proposed rule that the advance notice gave interested persons
ample time to assemble and articulate their thoughts and opinions.
Some of those persons who requested an extension of the comment
period themselves submitted lengthy comments, indicating that they
have already fully expressed their views. In light of these
considerations, extending the comment period was unnecessary.

Comments
Regarding Economic Impact of the Proposed Rule

Many
commenters expressed concern about how the proposed rule might
impact economically various businesses that deal in "hemp" products.
These economic considerations are addressed in the next section of
this document (regulatory certifications).

Regulatory
Certifications

Certain
provisions of Federal law and executive orders (specified below)
require agencies to assess how their rules might impact the economy,
small businesses, and the states. (Hereafter in this document, these
provisions will be referred to collectively as the "certification
provisions.") DEA has conducted these certifications. However,
before discussing the economics, the nature of this rule should be
reiterated. This rule revises the wording of the DEA regulations to
clarify for the public the agency's understanding of longstanding
federal law. In other words, through this rule, DEA is implementing
what it believes to be the mandate of Congress under the CSA. (This
mandate is that every substance containing THC be listed in schedule
I, unless the substance is specifically exempted from control or
listed in another schedule.) Regardless of how this rule might
impact the economy, small businesses, or the states, DEA must carry
out the mandate.
It is also critical to bear in mind that only a very narrow category
of "hemp" products will be prohibited under the rules that DEA is
publishing today. As a result of the exemptions issued by DEA under
the interim rule, all "hemp" products that do not cause THC to enter
the human body are entirely exempted from control, regardless of
their THC content. Thus, items such as "hemp" clothing, industrial
solvents, personal care products, and animal feed mixtures are
considered noncontrolled substances (not subject to any of the CSA
requirements) regardless of their THC content. This rule therefore
causes no economic impact whatsoever on such exempted products.
It also must be considered that when Congress enacted the CSA, it
created a system of controls that was comprehensive in scope to
protect the general welfare of the American people within the
context of the Act.\16\ Incidental restrictions on economic activity
resulting from enforcement of the CSA have never been viewed as a
proper basis to cease such enforcement. The certification provisions
are no exception to this principle.

[\16\ See 21
U.S.C. 801(2).]

Moreover, one
of the chief aims of the certification provisions is to ensure that
agencies consider the potential economic ramifications of imposing
new regulations. This rule, however, does not create any new
category of regulation governing the handling of controlled
substances. Rather, the rule merely helps to clarify what products
are, or are not, subject to what DEA believes are preexisting CSA
requirements.
DEA recognizes, however, that some members of the public disagree
with DEA's interpretation of the law with respect to THC. As a
result, some companies may be continuing to market in the United
States "hemp" food and beverage products that contain THC.
Accordingly, for purposes of calculating the economic impact of
these rules, DEA has assumed THC-containing "hemp" foods and
beverages are lawful products until this rule becomes final.
In the regulatory certifications that accompanied the proposed rule,
DEA explained in detail its analysis of the economic activity
relating to "hemp" food and beverage products (referred to therein
and hereafter in this document as "edible `hemp' products"). 66 FR
at 51536-51537. In that analysis, using conservative assumptions
(erring on the side of inclusiveness), DEA estimated that the total
sales of edible "hemp" products in the United States is no more than
$20 million per year with no more than 500 persons employed in
connection with these products. In the publication of the proposed
rule, DEA urged any manufacture or distributor of "hemp" products to
submit during the comment period any data on this economic activity
that might warrant adjustments to these estimates. The comments that
DEA received suggest that the agency might have overestimated the
amount of economic activity tied to edible "hemp" products. The
highest estimate submitted by representatives of businesses that
produce and distribute edible "hemp" products was that the total
sales of such products in the United States is approximately $6
million.
It also must be noted that not every such edible product marketed as
a "hemp" product is necessarily prohibited under the rule being
finalized today. As DEA stated repeatedly in the text accompanying
the proposed rule and the interim rule, if a product says "hemp" on
the label but contains no THC (or any other controlled substance),
it is not a controlled substance and, therefore, not affected by
this rule. At least one "hemp" food company claims that its products
are THC-free.\17\ If this is correct, such products are not
controlled substances and not prohibited by the CSA. Thus, even if
the edible "hemp" products business is a $6 million industry in the
United States, some of that business might be able to continue under
this final rule.

[\17\ On
January 28, 2002, a company that sells "hemp" food products issued
the following statement on its website (http://www.thehempnut.com):
It is the position of HempNut, Inc. and the Hemp Food Association (HFA)
that this Rule [published by DEA on October 9, 2001] is merely a
clarification and confirmation of the basis under which DEA, US
Customs, and all responsible hempseed importers have already been
operating under for quite some time, namely, that hempseed products
may not contain tetrahydrocannabinol (THC). A survey of hempseed
importers revealed that all were in full compliance with the Rule,
and have
no THC in their products.]

The one other
category of products that might be impacted economically by this
rule is that in which pure cannabis seeds are sold as birdseed. (As
set forth in the interim rule, which is being finalized today, DEA
is exempting animal feed mixtures containing sterilized cannabis
seeds with other ingredients, but not pure sterilized cannabis
seeds.) In the regulatory certifications attached to the proposed
rule, DEA estimated that no more than $77,000 worth of birdseed that
contains cannabis seeds is imported into the United States for sale
in this country. It appears likely that most of this birdseed is
sold in a mixture that is exempted under the interim rule.
Accordingly, the total amount of pure "hempseeds" sold as birdseed
in this country is probably much less than $77,000.

Regulatory
Flexibility Act

For the
reasons provided above, the Acting Administrator hereby certifies
that this rule will not have a significant impact on a substantial
number of small entities within the meaning of the Regulatory
Flexibility Act (5 U.S.C. 605(b)). The economic activity that would
be disallowed under this rule is already illegal under DEA's
interpretation of existing law. Even if one were to assume that such
economic activity were legal under current law, the prohibition on
such activity resulting from this rule (summarized above) would not
constitute significant impact on a substantial number of small
entities within the meaning of the Regulatory Flexibility Act.
Therefore, a final regulatory flexibility analysis is not required
for this rule.

Executive
Order 12866

This rule has
been drafted and reviewed in accordance with Executive Order 12866,
Regulatory Planning and Review, 1(b), Principles of Regulation. This
rule has been determined to be a "significant regulatory action"
under Executive Order 12866, 3(f). Accordingly, this rule has been
reviewed by the Office of Management and Budget for purposes of
Executive Order 12866.

Executive
Order 13132

This rule
does not preempt or modify any provision of state law; nor does it
impose enforcement responsibilities on any state; nor does it
diminish the power of any state to enforce its own laws.
Accordingly, this rule does not have federalism implications
warranting the application of Executive Order 13132.

Executive
Order 12988--Civil Justice Reform

This rule
meets the applicable standards set forth in sections 3(a) and
3(b)(2) of Executive Order 12988.

Unfunded
Mandates Reform Act of 1995

This rule
will not result in the expenditure by State, local, and tribal
governments, in the aggregate, or by the private sector, of
$100,000,000 or more in any one year. Therefore, no actions are
necessary under the Unfunded Mandates Reform Act of 1995.

Small
Business Regulatory Enforcement Fairness Act of 1996

For the
reasons provided above, this rule is not likely to result in any of
the following: An annual effect on the economy of $100,000,000 or
more; a major increase in costs or prices for consumers, individual
industries, federal, state, or local government agencies, or
geographic regions; or significant adverse effects on competition,
employment, investment, productivity, innovation, or on the ability
of United States-based enterprises to compete with foreign-based
enterprises in domestic and export markets. The economic activity
disallowed under this rule is already illegal under DEA's
interpretation of existing law. Even if one were to assume that such
economic activity were legal under current law, the prohibition on
such activity resulting from this rule would not render the rule a
major rule under the Small Business Regulatory Enforcement Fairness
Act of 1996 (SBREFA), 5 U.S.C. 804. Therefore, the provisions of
SBREFA relating to major rules are inapplicable to this rule.
However, a copy of this rule has been sent to the Office of
Advocacy, Small Business Administration. Further, a copy of this
final rule will be submitted to each House of the Congress and to
the Comptroller General in accordance with SBREFA (5 U.S.C. 801).

Paperwork
Reduction Act of 1995

This rule
does not involve collection of information within the meaning of the
Paperwork Reduction Act of 1995.

Pursuant to
the authority vested in the Attorney General under sections 201,
202, and 501(b) of the CSA (21 U.S.C. 811, 812, and 871(b)),
delegated to the Administrator and Deputy Administrator pursuant to
section 501(a) (21 U.S.C. 871(a)) and as specified in 28 CFR 0.100
and 0.104, appendix to subpart R, sec. 12, the Acting Administrator
hereby orders that Title 21 of the Code of Federal Regulations, part
1308, be amended as follows:

PART
1308--[AMENDED]

1. The
authority citation for part 1308 continues to read as follows:

Authority: 21
U.S.C. 811, 812, 871(b), unless otherwise noted.

2. Section
1308.11(d)(27) is revised to read as follows:

Sec.
1308.11 Schedule I.

* * * * *
(d) * * *
(27) Tetrahydrocannabinols--7370
Meaning tetrahydrocannabinols naturally contained in a plant of the
genus Cannabis (cannabis plant), as well as synthetic equivalents of
the substances contained in the cannabis plant, or in the resinous
extractives of such plant, and/or synthetic substances, derivatives,
and their isomers with similar chemical structure and
pharmacological activity to those substances contained in the plant,
such as the following:
1 cis or trans tetrahydrocannabinol, and their optical isomers
6 cis or trans tetrahydrocannabinol, and their optical isomers
3, 4 cis or trans tetrahydrocannabinol, and its optical isomers

(Since
nomenclature of these substances is not internationally
standardized, compounds of these structures, regardless of numerical
designation of atomic positions covered.)

Exemption
From Control of Certain Industrial Products and Materials Derived
From the Cannabis Plant

AGENCY:
Drug Enforcement Administration, Department of Justice.

ACTION:
Final rule.

SUMMARY:
The Drug Enforcement Administration (DEA) is adopting as final an
interim rule exempting from control (i.e., exempting from all
provisions of the Controlled Substances Act (CSA)) certain items
derived from the cannabis plant and containing tetrahydrocannabinols
(THC). Specifically, the interim rule exempted THC-containing
industrial products, processed plant materials used to make such
products, and animal feed mixtures, provided they are not used, or
intended for use, for human consumption (and therefore cannot cause
THC to enter the human body).

What Does
This Rule Accomplish and by What Authority Is It Being Issued?

This final
rule revises the DEA regulations to add a provision exempting from
CSA control certain THC-containing industrial products, processed
plant materials used to make such products, and animal feed
mixtures, provided such products, materials, and feed mixtures are
made from those portions of the cannabis plant that are excluded
from the definition of marijuana and are not used, or intended for
use, for human consumption. Among the types of industrial products
that are exempted as a result of this final rule are: (i) Paper,
rope, and clothing made from cannabis stalks; (ii) processed
cannabis plant materials used for industrial purposes, such as fiber
retted from cannabis stalks for use in manufacturing textiles or
rope; (iii) animal feed mixtures that contain sterilized cannabis
seeds and other ingredients (not derived from the cannabis plant) in
a formulation designed, marketed, and distributed for animal
(nonhuman) consumption; and (iv) personal care products that contain
oil from sterilized cannabis seeds, such as shampoos, soaps, and
body lotions (provided that using such personal care products does
not cause THC to enter the human body).
This rule is being issued pursuant to 21 U.S.C. 811, 812, and
871(b). Sections 811 and 812 authorize the Attorney General to
establish the schedules in accordance with the CSA and to publish
amendments to the schedules in the Code of Federal Regulations, part
1308 of Title 21. Section 871(b) authorizes the Attorney General to
promulgate and enforce any rules, regulations, and procedures which
he may deem necessary and appropriate for the efficient enforcement
of his functions under the CSA. In addition, the Attorney General is
authorized to exempt, by regulation, any compound, mixture, or
preparation containing any controlled substance from the application
of all or any part of the CSA if he finds such compound, mixture, or
preparation meets the requirements of section 811(g)(3). These
functions vested in the Attorney General by the CSA have been
delegated to the Administrator and Deputy Administrator of DEA. 21
U.S.C. 871(a); 28 CFR 0.100(b) and 0.104, appendix to subpart R,
sec. 12.

Why Is DEA
Exempting From Control Certain THC-Containing Substances Not
Intended for Human Consumption?

Without the
exemptions made by the interim rule, which are adopted as final in
this rule, a wide variety of legitimate industrial products derived
from portions of the cannabis plant would be considered schedule I
controlled substances. For example, paper, rope, and clothing (made
using fiber from cannabis stalks) and industrial solvents,
lubricants, and bird seed mixtures (made using sterilized cannabis
seeds or oil from such seeds) would, in the absence of the interim
rule, be considered schedule I controlled substances if they
contained THC. If such products were considered schedule I
controlled substances, their use would be severely restricted.\1\
Under the interim rule, however, which DEA is adopting as final
here, DEA exempted such legitimate industrial products from control,
provided they are not used, or intended for use, for human
consumption. As explained below, DEA believes this approach protects
the public welfare within the meaning of the CSA while striking a
fair balance between the plain language of the Act and the intent of
Congress under prior marijuana legislation.

[\1\ The CSA
and DEA regulations permit industrial use of schedule I controlled
substances, but only under strictly regulated conditions.]

THC is an
hallucinogenic substance with a high potential for abuse. Congress
recognized this fact by placing it in schedule I of the CSA. Because
of this, there are only two ways that THC may lawfully enter a
person's body: (1) If the THC is contained in a drug product that
has been approved by the Food and Drug Administration (FDA) as being
safe and effective for human use; \2\ or (2) if an experimental drug
containing THC is provided to a research subject in clinical
research that has been approved by FDA and conducted by a researcher
registered with DEA.\3\ Disallowing human consumption of schedule I
controlled substances except in the foregoing limited circumstances
is an absolute necessity to conform with the CSA and protect the
public welfare within the meaning of the Act.\4\

[\2\ 21 U.S.C.
331, 355, 811(b), 812(b). At present, Marinol[reg] is the only
THC-containing drug product that has been approved for marketing by
FDA. Marinol[reg] is the brand name of a product containing
synthetic dronabinol (a form of THC) in sesame oil and encapsulated
in soft gelatin capsules that has been approved for the treatment of
nausea and vomiting associated with cancer chemotherapy as well as
the treatment of anorexia associated with weight loss in patients
with AIDS. Because Marinol[reg] is the only THC-containing drug
approved by FDA, it is the only THC-containing substance listed in a
schedule other than schedule I. DEA recently transferred Marinol[reg]
from schedule II to schedule III, thereby lessening the CSA
regulatory requirements governing its use as medicine. See 64 FR
35928 (1999).

\3\ 21 U.S.C.
823(f); 21 CFR 5.10(a)(9), 1301.18, 1301.32.

\4\ In
enacting the CSA, Congress stated: "The illegal importation,
manufacture, distribution, and possession and improper use of
controlled substances have a substantial and detrimental effect on
the health and general welfare of the American people." 21 U.S.C.
801(2).]

Where,
however, a schedule I controlled substance is contained in a product
not used for human consumption, the CSA provides DEA with
discretionary authority to issue regulations exempting such product
from control.\5\ DEA has carefully considered whether it is
appropriate to exercise this discretionary authority when it comes
to industrial "hemp" products (i.e., products made from portions of
the cannabis plant excluded from the CSA definition of marijuana).
The text of the CSA and its legislative history make no mention of
industrial uses of the cannabis plant. However, DEA has taken into
account that, under prior legislation (the Marihuana Tax Act of
1937), Congress intended to permit the use of certain
cannabis-derived industrial products. The Senate Report accompanying
the 1937 Act stated:

[\5\ See 21
U.S.C. 811(g)(3); see also 21 U.S.C. 871(b) (providing discretionary
authority to DEA Administrator to "promulgate and enforce any rules,
regulations, and procedures which he may deem necessary and
appropriate for the efficient execution of his functions under [the
CSA].").]

The
[cannabis] plant * * * has many industrial uses. From the mature
stalks, fiber is produced which in turn is manufactured into twine,
and other fiber products. From the seeds, oil is extracted which is
used in the manufacture of such products as paint, varnish,
linoleum, and soap. From hempseed cake, the residue of the seed
after the oil has been extracted, cattle feed and fertilizer are
manufactured. In addition, the seed is used as a special feed for
pigeons.
S. Rep. No. 900, 75th Cong., 1st Sess., at 2-3 (1937). DEA
recognizes that the intent of Congress in 1937 to allow the
foregoing industrial "hemp" products is no longer controlling
because the CSA (enacted in 1970) repealed and superseded the 1937
Marihuana Tax Act. DEA further recognizes that the allowance that
Congress made for such products under the now-rescinded Marihuana
Tax Act was based on a 1937 assumption (now refuted) that such
products contained none of the psychoactive drug now known as THC.
(In contrast, when Congress enacted the CSA in 1970, it expressly
declared that anything containing THC is a schedule I controlled
substance.) \6\ Still, for the reasons provided below, DEA believes
it is an appropriate exercise of the Administrator's discretionary
authority under the CSA to issue an exemption allowing the
legitimate industrial uses of "hemp" that were allowed under the
1937 Act. At the same time, DEA has been careful to ensure that this
exemption comports with the CSA by maintaining the rule that no
humans may lawfully take THC into their bodies except when they are
(i) using an FDA-approved drug product or (ii) the subjects of
FDA-authorized research.

[\6\ A
detailed comparison of the 1937 Marihuana Tax Act and the CSA is
provided in the October 9, 2001 interpretive rule. 66 FR at
51530-51531.]

DEA may not
arbitrarily exempt a controlled substance from application of the
CSA. Rather, such an exemption must be based on a provision of the
CSA. As cited above, the exemption of certain "hemp" products under
this final rule is issued pursuant to two CSA provisions: 21 U.S.C.
811(g)(3)(B) and 871(b).
Pursuant to 811(g)(3)(B), the Administrator of DEA may exempt from
control "[a] compound, mixture, or preparation which contains any
controlled substance, which is not for administration to a human
being or animal, and which is packaged in such form or
concentration, or with adulterants or denaturants, so that as
packaged it does not present any significant potential for abuse."
This provision, which was added to the CSA in 1984, was aimed
primarily at analytic standards and preparations which are not for
use in humans and pose no significant abuse threat by nature of
their formulation. It bears emphasis, however, that Congress did not
mandate that DEA exempt from control all mixtures and preparations
that DEA determines meet the criteria of section 811(g)(3)(B).
Rather, as the word "may" in the first line of section 811(g)(3)
indicates, Congress gave DEA discretionary authority to issue such
exemptions.
The DEA regulation that implements section 811(g)(3)(B) is 21 CFR
1308.23. Section 1308.23(a) provides that the Administrator may
exempt from control a chemical preparation or mixture containing a
controlled substance that is "intended for laboratory, industrial,
educational, or special research purposes and not for general
administration to a human being or other animal" if it is packaged
in such a form or concentration, or with adulterants or denaturants,
so that the presence of the controlled substance does not present
any significant potential for abuse.
DEA believes that industrial "hemp" products such as paper,
clothing, and rope, when used for legitimate industrial purposes
(not for human consumption) meet the criteria of section
811(g)(3)(B) and Sec. 1308.23. Legitimate use of such products
cannot result in THC entering the human body. Moreover, allowing
these products to be exempted from CSA control in no way hinders the
efficient enforcement of the CSA. Accordingly, DEA believes that
these types of industrial products should be exempted from
application of the CSA, provided they are not used, or intended for
use, for human consumption. For the same reasons, processed cannabis
plant materials that cannot readily be converted into any form that
can be used for human consumption, and which are used in the
production of such legitimate industrial products, are being
exempted from control under this final rule.
The use of sterilized cannabis seeds \7\ that contain THC in animal
feed fails to meet the criteria of section 811(g)(3)(B) and section
1308.23 because this involves the use of a controlled substance
(THC) in animals.\8\ Nonetheless, pursuant to 21 U.S.C. 871(b), DEA
believes it is appropriate to exempt from application of the CSA
animal feed mixtures containing such seeds, provided the seeds are
mixed with other ingredients that are not derived from the cannabis
plant in a formulation designed, marketed and distributed for animal
consumption (not for use in humans). Section 871(b) authorizes the
Attorney General to promulgate and enforce any rules, regulations,
and procedures which he may deem necessary and appropriate for the
efficient enforcement of his functions under the CSA. It should be
underscored that section 871(b) is not a catchall provision that can
be used to justify any exemption. For the following reasons,
however, DEA believes that the use of sterilized cannabis seeds in
animal feed mixtures is a unique situation that warrants an
exemption pursuant to section 871(b).

[\7\ Unless
otherwise indicated, all references in this document to "cannabis
seeds" or " `hemp' seeds" refer to sterilized seeds (incapable of
germination). In contrast to sterilized cannabis seeds, unsterilized
cannabis seeds fit within the CSA definition of marijuana and are
not exempted from control under this interim rule.

\8\ If,
however, the "hemp" seeds used in animal feed are sterilized
cannabis seeds that contain no THC, such seeds are not a controlled
substance. Under such circumstances, there is no need to exempt such
seeds from control.]

As stated
above and in the interpretive rule, the legislative history of the
1937 Marihuana Tax Act reveals that Congress expressly contemplated
allowing "hemp" animal feed. The 1937 Congress categorized such use
of "hemp" as a legitimate "industrial" use. It is true that the
intent of the 1937 Congress is no longer controlling since the CSA
repealed the 1937 Act and declared anything containing THC to be a
schedule I controlled substance. However, because neither the text
nor the legislative history of the CSA addresses the legality of
using sterilized cannabis seeds in animal feed, or the possibility
that such seeds might contain THC, what was viewed under the 1937
Act as "legitimate industrial use" of such seeds in animal feed
continued uninterrupted following the enactment of the CSA in 1970.
The historical lack of federal regulation of some THC-containing
products (whether based on differences between prior law and the
CSA, lack of awareness of the THC content of such product, or other
considerations) does not--by itself--justify exempting such product
from control under the CSA. DEA remains obligated to apply the
provisions of the CSA to all controlled substances absent a
statutory basis to exempt a particular substance from control.
However, with respect to animal feed mixtures containing sterilized
cannabis seeds, additional factors (combined with Congress' express
desire under prior legislation to allow such products) justify an
exemption pursuant to section 871(b). The presence of a controlled
substance in animal feed poses less potential for abuse than in a
product intended for human use and does not entail the
administration of THC to humans. Moreover, when sterilized cannabis
seeds are mixed with other animal feed ingredients and not designed,
marketed, or distributed for human use, there is minimal risk that
they will be converted into a product used for human consumption.
Therefore, such legitimate use in animal feed mixtures poses no
significant danger to the public welfare. Accordingly, given the
unique circumstances and history surrounding the use of sterilized
cannabis seeds in animal feed, DEA believes that it comports with
the CSA to continue to treat such activity as a legitimate
industrial use--not subject to CSA control--provided the foregoing
conditions are met.

How Is
"Human Consumption" Defined Under This Rule?

Under this
final rule, a material, compound, mixture, or preparation containing
THC will be considered "used for human consumption" (and therefore
not exempted from control) if it is: (I) Ingested orally or (ii)
applied by any means such that THC enters the human body. A
material, compound, mixture, or preparation containing THC will be
considered "intended for use for human consumption" and, therefore,
not exempted from control if it is: (i) Designed by the manufacturer
for human consumption; (ii) marketed for human consumption; or (iii)
distributed, exported, or imported with the intent that it be used
for human consumption.
In any legal proceeding arising under the CSA, the burden of going
forward with the evidence that a material, compound, mixture, or
preparation containing THC is exempt from control pursuant to this
rule shall be upon the person claiming such exemption. 21 U.S.C.
885(a)(1). In order to meet this burden with respect to a product or
processed plant material that has not been expressly exempted from
control by the Administrator pursuant to 21 CFR 1308.23 (as
explained below under the heading "What Is the Control Status of
Personal Care Products Made from 'Hemp'?"), the person claiming the
exemption must present rigorous scientific evidence, including
well-documented scientific studies by experts trained and qualified
to evaluate the effects of drugs on humans.

How Are
"Processed Plant Material" and "Animal Feed Mixture" Defined Under
This Rule?

Under this
final rule, any portion of the cannabis plant excluded from the CSA
definition of marijuana will be considered "processed plant
material" if it has been subject to industrial processes, or mixed
with other ingredients, such that it cannot readily be converted
into any form that can be used for human consumption. For example,
fiber that has been separated from the mature stalks by retting for
use in textiles is considered processed plant material, which is
exempted from control, provided it is not used, or intended for use,
for human consumption. In comparison, mature stalks that have merely
been cut down and collected do not fit within the definition of
"processed plant material" and, therefore, are not exempted from
control. As another example, if a shampoo contains oil derived from
sterilized cannabis seeds, one would expect that, as part of the
production of the shampoo, the oil was subject to industrial
processes and mixed with other ingredients such that, even if some
THC remains in the finished product, the shampoo cannot readily be
converted into a product that can be consumed by humans. Under such
circumstances, the product is exempted from control under this final
rule. In comparison, a personal care product that consists solely of
oil derived from cannabis seeds does not meet the definition of
"processed plant material" under this final rule and, therefore, is
not exempted from control.
"Animal feed mixture" is defined under this final rule to mean
sterilized cannabis seeds mixed with other ingredients in a
formulation that is designed, marketed, and distributed for animal
consumption (and not for human consumption). For example, sterilized
cannabis seeds mixed with seeds from other plants and for sale in
pet stores fit within the definition of "animal feed mixture" and
are exempted from control under this final rule provided the feed
mixture is not used, or intended for use, for human consumption. (In
contrast, a container of pure sterilized cannabis seeds--mixed with
no other ingredients--does not meet the definition of "animal feed
mixture" under this final rule and, therefore, is not exempted from
control.)

Which
"Hemp" Products Are Exempted From Control Under This Rule?

It is
impossible to list every potential product that might be made from
portions of the cannabis plant excluded from the definition of
marijuana. Therefore, DEA cannot provide an exhaustive list of
"hemp" products that are exempted from control under this final
rule. Nonetheless, in order to provide some guidance to the public,
the following are some of the more common "hemp" products that are
exempted (noncontrolled) under this final rule, provided they are
not used, or intended for use, for human consumption: paper, rope,
and clothing made from fiber derived from cannabis stalks,
industrial solvents made with oil from cannabis seeds, and bird seed
containing sterilized cannabis seed mixed with seeds from other
plants (or other ingredients not derived from the cannabis plant).
Personal care products (such as lotions and shampoos) made with oil
from cannabis seeds are also generally exempted, as explained below.

Which
"Hemp" Products Are Not Exempted From Control Under This Rule?

Other than
those substances that fit within the exemption being issued in this
final rule, all other portions of the cannabis plant, and products
made therefrom, that contain any amount of THC are schedule I
controlled substances.
Again, because one cannot list every conceivable "hemp" product, it
is impossible to examine here every "hemp" product for a
determination of whether such product is used, or intended for use,
for human consumption within the meaning of this final rule.
Therefore, this document contains no exhaustive list of "hemp"
products that are not exempted from control under this final rule.
Nonetheless, to provide some guidance, the following are some of the
"hemp" products that are not exempted from control under this final
rule (and therefore remain controlled substances) if they contain
THC: any food or beverage (such as pasta, tortilla chips, candy
bars, nutritional bars, salad dressings, sauces, cheese, ice cream,
and beer) or dietary supplement.

What Is
the Control Status of Personal Care Products Made From "Hemp"?

DEA has not
conducted chemical analyses of all of the many and varied personal
care products that are marketed in the United States, such as
lotions, moisturizers, soaps, or shampoos that contain oil from
sterilized cannabis seeds. Indeed, it appears that there is no
reliable source of information on these products. Accordingly, DEA
does not know whether every personal care product that is labeled a
"hemp" product necessarily was made using portions of the cannabis
plant, and if so, whether such portions of the plant are those
excluded from the definition of marijuana. Even if one assumes that
a product that says "hemp" on the label was made using cannabis
seeds or other portions of the plant, one cannot automatically
infer, without conducting chemical analysis, that the product
contains THC.\9\ Assuming, however, that a "hemp" product does
contain THC, and assuming further that such product is marketed for
personal care (e.g., body lotion or shampoo), the question remains
whether the use of the product results in THC entering the human
body. DEA is unaware of any scientific evidence that definitively
answers this question. Therefore, DEA cannot state, as a general
matter, whether "hemp" personal care products are exempted from
control under this final rule. Nonetheless, given the information
currently available, DEA will assume, unless and until it receives
evidence to the contrary, that most personal care products do not
cause THC to enter the human body and, therefore, are exempted under
this final rule. For example, DEA assumes at this time that lotions,
moisturizers, soaps, and shampoos that contain oil from sterilized
cannabis seeds meet the criteria for exemption under this final rule
because they do not cause THC to enter the human body and cannot be
readily converted for human consumption. However, if a personal care
"hemp" product is formulated and/or designed to be used in a way
that allows THC to enter the human body, such product is not
exempted from control under this final rule.

[\9\ Any
product that (i) is made from portions of the cannabis plant
excluded from the CSA definition of marijuana and (ii) contains no
THC (nor any other controlled substance) is not a controlled
substance.]

Again, it
must be emphasized that, although DEA believes that most personal
care "hemp" products currently marketed in the United States meet
the criteria for exemption under this final rule, it is not possible
for DEA to provide an exhaustive list of every such product and to
state whether such product is exempted. Should manufacturers,
distributors, or importers of "hemp" personal care products wish to
have their products expressly exempted from control, they should
take steps to determine whether such products contain THC and, if
they do contain THC, whether use of the products results in THC
entering the human body. Any such manufacturer, distributor, or
importer who believes that its product satisfies the criteria for
exemption under this final rule may request that DEA expressly
declare such product exempted from control by submitting to DEA an
application for an exemption, together with appropriate scientific
data, in accordance with the procedures set forth in 21 CFR
1308.23(b) and (c).
A manufacturer, distributor, or importer of a "hemp" product that
meets the criteria for exemption under this final rule need not
obtain an express exemption from DEA in order to continue to handle
such product. Rather, this is a voluntary procedure. DEA leaves it
to the individual manufacturer, distributor, or importer to decide
whether there is sufficient uncertainty about its product to seek an
express exemption from DEA. However, any person who continues to
handle a "hemp" product that does not meet the criteria for an
exemption under this final rule is subject to liability under the
CSA.

What Is
the Legal Status of "Hemp" Products That Contain No THC?

Any portion
of the cannabis plant, or any product made therefrom, or any product
that is marketed as a "hemp" product, that is both excluded from the
definition of marijuana and contains no THC--natural or
synthetic--(nor any other controlled substance) is not a controlled
substance. Accordingly, such substances need not be exempted from
control under this final rule, since they are, by definition,
noncontrolled.

What Is
the Justification for Issuing the Exemptions Under This Rule?

DEA believes
it is both necessary for the most effective enforcement of the CSA
and consistent with the public interest to allow the exemptions
contained in this rule. Otherwise, as provided in the CSA and DEA
regulations, all products containing any amount of THC are schedule
I controlled substances. In other words, in the absence of this
final rule, legitimate industrial "hemp" products such as paper,
rope, clothing, and animal feed mixtures would be schedule I
controlled substances if they contain THC. Thus, without the
exemptions that are being finalized in this rule, anyone who sought
to import such products for legitimate industrial uses would need to
obtain a DEA registration and an import permit. 21 U.S.C. 952(a)(2),
957(a). Likewise, distributors of such products would need a DEA
registration and would be required to utilize DEA order forms and
maintain strict records of all transactions. 21 U.S.C. 822(a)(1),
827(a), 828(a). DEA believes that such regulatory requirements are
unnecessary to protect the public welfare and achieve the goals of
the CSA, provided such products are not used, or intended for use,
for human consumption. Furthermore, DEA believes that it would not
be an appropriate prioritization of limited agency resources to take
on the responsibility of regulating these products as schedule I
controlled substances when they are not being used for human
consumption. Therefore, as long as there is no possibility that
humans will consume THC by using something other than an
FDA-approved drug product or a product that the FDA has authorized
for clinical research, DEA believes that it is consistent with the
purposes and structure of the CSA to exempt industrial "hemp"
products, processed plant materials, and animal feed mixtures in the
manner specified in this final rule.

What Are
the Registration Requirements for Handlers of "Hemp" Products Under
This Final Rule?

In light of
the exemptions provided under this rule, the following registration
requirements should be considered:
Who must obtain a registration--Persons who wish to manufacture or
distribute any THC-containing product or plant material that is not
exempted from control under this rule must apply for the
corresponding registration to handle a schedule I controlled
substance. Absent such registration, it is unlawful to manufacture,
distribute, or dispense, import, or export any such product or plant
material. 21 U.S.C. 822(b), 841(a)(1), 957(a), 960(a). The
circumstances under which DEA may grant registrations to handle
schedule I controlled substances are limited, as set forth in 21
U.S.C. 823.
In addition, no person may cultivate the cannabis plant for any
purpose except when expressly registered with DEA to do so. This has
always been the case since the enactment of the CSA. 21 U.S.C.
822(b), 823(a); 21 CFR Part 1301; see New Hampshire Hemp Council,
Inc. v. Marshall, 203 F.3d 1 (1st Cir. 2000). Further, the CSA
prohibits the importation of schedule I controlled substances except
as authorized by 21 U.S.C. 952(a)(2). Similarly, the CSA prohibits
the exportation of schedule I nonnarcotic controlled substances
except as authorized by 21 U.S.C. 953(c).
Who need not obtain a registration--Persons who import and
distribute "hemp" products and processed cannabis plant material
that are exempted from control under this final rule are not subject
to any of the CSA requirements, including the requirement of
registration. For example, a person who imports "hemp" clothing is
not considered to be importing a controlled substance and is,
therefore, not subject to any of the CSA requirements. Similarly, a
person who has imported into the United States processed cannabis
plant material that is exempted under this rule (such as retted
fiber) and converts such material into an exempted "hemp" product
(such as clothing) is not considered to be manufacturing a
controlled substance and, therefore, need not obtain a controlled
substance manufacturing registration.
It is worth repeating here that, if a product marketed as a "hemp"
product actually contains no THC (or any other controlled
substance), it is noncontrolled and handlers of the product are not
subject to any of the CSA provisions, such as the registration
requirement.

Comments
That DEA Received in Response to the Interim Rule

Following
publication of the interim rule, DEA received comments from
thousands of individuals and groups. The comments were in the form
of original letters, form letters, petitions, and a cookbook. Those
who submitted comments included companies that manufacture and
distribute various "hemp" products, associations that represent such
manufacturers and distributors, domestic and Canadian government
officials, and individuals. In accordance with the Administrative
Procedure Act, DEA carefully considered all of the comments it
received.
Most of the comments that DEA received relate to both of the rules
that DEA published on October 9, 2001: (i) DEA 205 (66 FR 51535), a
proposed rule, which proposed to clarify that the listing of THC
includes both natural and synthetic THC and (ii) DEA 206 (66 FR
51539), an interim rule, which exempted certain THC-containing
products and plant materials from control. Those comments that DEA
received which pertain primarily to the interim rule are addressed
here. Those comments which pertain primarily to the proposed rule
are addressed in the final DEA 205 rule, which appears in a separate
Federal Register document that immediately precedes this
document. Both DEA 205 and DEA 206 contain a summary of the
pertinent comments, along with an explanation of how DEA considered
them in deciding to finalize the rules.
The number of individuals and groups that participated in the
comment process far exceeded the number of different issues raised.
The issues raised overlapped to a large extent as many persons
submitted form letters or signed petitions written by groups which
themselves submitted lengthy comments. In this document, together
with the final proposed rule, DEA has addressed all the major issues
raised by the commenters. Some of these issues are addressed above
in the text that precedes this section. The remaining issues are
addressed below.

Comments
Regarding Which Products To Exempt From Control

None of the
commenters objected to the basic purpose of this rule: To exempt
from control certain THC-containing industrial products and animal
feed mixtures made from "hemp" (portions of the cannabis plant
excluded from the definition of marijuana). To the contrary, all the
commenters who expressed an opinion on this particular issue agreed
with these exemptions.\10\ However, many commenters said that DEA
should go further by also exempting "hemp" food and beverage
products that contain THC. DEA declined to adopt this suggestion for
the reasons provided herein.

[\10\ Some
commenters were under the mistaken impression that DEA failed to
exempt any products from control. These commenters asked DEA to
exempt what DEA had already exempted under the interim rule. For
example, several commenters objected to DEA's supposed failure to
exempt "hemp" clothing and paper, even though the interim rule
stated repeatedly that such products were being exempted.]

Those
commenters who requested that DEA exempt THC-containing "hemp" food
and beverage products made two main claims in support of this
request: (i) That "hemp" foods and beverages contain only minimal
amounts of THC, which, they asserted, cannot cause any psychoactive
effects; and (ii) that the oil from "hemp" seeds (sterilized
cannabis seeds) provides nutritional value and is a safe food
ingredient.\11\

[\11\ Some
commenters also expressed concern about the economic impact of
disallowing THC-containing "hemp" food and beverage products. This
issue is addressed in the final 205 rule, in the regulatory
certifications.]

As to the
issue of THC content, many of the comments appeared to be asking DEA
simply to assume that the placement of the word "hemp" on the label
of a food or beverage product automatically means that the product
contains a certain low amount of THC. In fact, the existence of the
word "hemp" on the label of a food container provides no definitive
proof of its contents. The FDA cannot and does not evaluate the
contents of every food product sold in the United States. Since
there is no reliable information about the contents of all foods and
beverages marketed as "hemp" products, it cannot automatically be
assumed that all such products will never cause a psychoactive
effect or a positive drug test for THC.
One scientific study published in 1997 examined "hemp" salad oil
(containing oil from cannabis seeds) sold in "hemp shops" and health
food stores in Switzerland. The authors of the study stated that all
the human subjects who ate the cannabis seed oil reported
THC-specific psychotropic symptoms and had urine samples positive
for THC.\12\ In citing this study, DEA is not suggesting that all
"hemp" food and beverage products cause psychoactive effects.
Rather, DEA mentions this study in response to the assertions made
by some commenters that eating "hemp" foods cannot possibly cause
psychoactive effects.\13\

\13\ In a
later study, financed by various "hemp" companies, human subjects
were given oil from cannabis seeds containing lower doses of THC
than in the Lehman study. G. Leson, et al., Evaluating the Impact of
Hemp Food Consumption on Workplace Drug Tests, Journal of Analytic
Toxicology, vol. 25 (November/December 2001). The authors of this
study reported that ingestion of cannabis seed oil containing these
lower doses of THC resulted in little or no positive screening for
THC, depending on the amount of THC consumed and the sensitivity of
the urine testing. Companies who financed this study assert that the
lower THC content given to the subjects of this study is
commensurate with the current methods employed by these companies
for cleaning the cannabis seeds before removing the oil from them
for use in food products.]

Attached to
one of the comments was another study, which was also financed by
various "hemp" companies. This study, entitled "Assessment of
Exposure to and Human Health Risk from THC and other cannabinoids in
hemp foods," reached similar conclusions about the reduced levels of
THC in currently marketed "hemp" foods and the diminished likelihood
of testing positive for THC when consuming such products.
As for the comments claiming that "hemp" foods provide essential
nutrients and are safe to eat, it is not DEA's role under the CSA to
assess the nutritional value or safety of foods.\14\ Regardless of
whether the oil from cannabis seeds contains certain nutrients,\15\
the CSA does not provide for DEA to exempt food products that
contain THC. As explained above and in the text accompanying the
interim rule, the CSA prohibits human consumption of "any quantity"
of a schedule I hallucinogenic substance outside of an FDA-approved
product or FDA-approved research. Other than drugs that have been
approved by the FDA for prescription use, or drugs that may be
lawfully sold over the counter without a prescription, DEA may not
exempt controlled substances to allow them to be used for human
consumption--even in the case of products that supposedly contain
only "trace amounts" of a controlled substance. 21 U.S.C. 811(g).
Thus, DEA may not, as some commenters proposed, pick an arbitrary
cutoff line allowing a certain percentage of THC in foods and
beverages. Moreover, notwithstanding the statutory prohibition, DEA
believes it would be inappropriate to attempt to establish an
acceptable level of schedule I hallucinogens in food products. For
example, it would not be appropriate to allow food products to
contain "trace amounts" of such other schedule I hallucinogens as
LSD or MDMA ("ecstasy"). Finding that it is contrary to the public
welfare to allow human consumption of "any quantity" of schedule I
hallucinogens, Congress did not give DEA the authority to determine
what constitutes a "safe amount" of such drugs in food.\16\

[\14\ In the
context of the CSA, the public "safety" (and DEA's role therein) is
implicated by the use of controlled substances for other than a
legitimate medical purpose or in any other manner not authorized by
the CSA.

\15\ Although
this rule is not a food safety measure, because DEA received so many
comments regarding this issue, some members of the public may be
interested in the following information. Under the Federal Food,
Drug, and Cosmetic Act, a substance that is added to food is not
subject to the requirement of premarket approval if its safety is
generally recognized among qualified scientific experts under the
conditions of its intended use. 21 U.S.C. 321(s). A substance added
to a food may be considered "generally recognized as safe" (GRAS)
through experience based on "common use in food," which requires a
substantial history of consumption for food use by a significant
number of consumers. 21 CFR 170.3(f), (h); 21 CFR 170.30. The FDA
evaluated an industry submission claiming GRAS status for certain
food uses of "hempseed oil" and expressly stated that it did not
believe the submission provided a sufficient basis to classify
"hempseed oil" as GRAS through experience based on common use in
food. See FDA Center for Food Safety & Applied Nutrition, Office of
Premarket Approval, Agency Response Letter, GRAS Notice No. GRN
00035 (August 24, 2000), reproduced at www.cfsan.fda.gov/rdb/opa-g035.html.
In making this determination, the FDA did not evaluate whether there
would be a basis for GRAS status through scientific procedures or
whether "hempseed oil" would meet the standard for premarket
approval as a food additive. Id.

\16\ To
establish a violation of the CSA, the government does not have to
prove that the controlled substance in question was of sufficient
quantity to produce a psychoactive effect. United States v. Nelson,
499 F.2d 965 (8th Cir. 1974).]

Accordingly,
DEA has limited the exemptions provided in this final rule to those
cannabis-derived "hemp" products that do not cause THC to enter the
human body.

Many
commenters asked the agency to indicate how it will determine
whether a food or beverage product contains THC. Under federal law,
it is legally sufficient to demonstrate a violation of the CSA based
on the presence of any measurable amount of a prohibited controlled
substance.\17\ Thus, the questions raised by the commenters are:
"What testing methods will DEA utilize to determine whether a food
product contains a measurable amount of
THC and how sensitive are such methods?"

DEA will
utilize testing assays or protocols used in standard analytical
laboratories that have demonstrated valid and reliable sensitivity
for the measurements of THC.\18\ The methodology, level of
sensitivity, and degree of testing accuracy in the fields of
analytical and forensic chemistry have evolved since the first
discovery of THC in the 1960s. A variety of analytical equipment,
testing methodologies, and protocols are described in the published
scientific literature.\19\ Such methods may include (but are not
limited to) gas chromatography, liquid chromatography, and mass
spectrometry analyses. DEA has not, and will not, utilize any one
method to the exclusion of others.\20\

[\18\ In this
context, "valid" means that the technique measures what it is
designed to measure, and "reliable" means that the technique can be
replicated by other laboratories.

\20\ What
constitutes the appropriate method of testing may vary depending on
the circumstances. In any criminal prosecution, civil or
administrative action, or other legal proceeding arising under the
CSA, where the government must prove the presence of a controlled
substance, the government may do so by the introduction of any
evidence sufficient under law to prove such fact. See, e.g., United
States v. Bryce, 208 F.3d 346, 352-354 (2d Cir. 2000).]

The lower
limit of detectability of these assays can vary according to
equipment, methodologies, and the form of the sample. Nonetheless,
using currently available analytical methodologies and extraction
procedures, it is reasonable to reproducibly and accurately detect
THC at or below 1 part per million in cannabis bulk materials or
products. Should more sensitive assays and analytical techniques be
developed in the future, DEA will refine its testing methods
accordingly.
Some companies that handle "hemp" food products have asked DEA
whether the agency would test the companies' products for THC
content. It is not within DEA's authority to serve as such a testing
laboratory for private entities. Nor would it be appropriate for DEA
to certify laboratories for these analyses. Manufacturers and
distributors of "hemp" food and beverage products may, of course,
conduct their own testing to determine to their own satisfaction
that their products contain no THC. However, they are under no
obligation to do so. Whether or not they conduct such testing, the
law remains the same: if a food or beverage product contains any
measurable amount of THC, it is an illegal schedule I controlled
substance; if it contains no THC, it is a legal, noncontrolled
substance.

Comments
Regarding Drug Screening

Several
commenters asserted that, in deciding whether or not to exempt
THC-containing food and beverage products, DEA should not concern
itself with the possibility that persons who eat such products then
undergo drug screening might test positive for THC. Some of these
commenters suggested that "hemp" food and beverage manufacturers
have taken steps to ensure that the amount of THC in their products
is low enough to avoid causing a positive drug screen. Given these
comments, it must be emphasized that, while effective drug screening
in appropriate circumstances is of concern to DEA and was part of
the agency's overall consideration, the ultimate decision about
which products to exempt from control did not turn on drug testing
considerations. Rather, as explained above, DEA exempted certain
products to the extent permissible by the CSA and consistent with
the public welfare within the meaning of the Act.
Although drug testing was not the basis for the exemptions, in view
of the comments about drug testing, it is worth reiterating that
there are no uniform standards of what constitutes a "hemp" product.
It cannot be said that, merely because a product has the word "hemp"
on the label, it will necessarily contain a certain low amount of
THC. Therefore, it cannot automatically be said that a food or
beverage product marketed as containing "hemp" will never cause a
positive drug test for THC. In fact, as noted above, one published
scientific study found that eating "hempseed" salad oil (of a
variety sold in "hemp shops" in Switzerland) did cause human
research subjects to test positive for THC.

Comments
Regarding the Cultivation of Cannabis for Industrial Purposes

Some
commenters asserted that the United States should promote the
cultivation of cannabis for industrial purposes based on economic
and environmental considerations. These commenters seemed to
misunderstand the nature of the rules being finalized today. The
rules do not impose restrictions on, or even address, the
cultivation of cannabis. Rather, as the text accompanying the rules
makes clear, the rules clarify which cannabis-derived products are
controlled and which are exempted from control.
As stated above, it has always been the case since the enactment of
the CSA in 1970 that any person who seeks to lawfully grow cannabis
for any purpose (including the production of "hemp" for industrial
purposes) must obtain a DEA registration. This requirement remains
in effect and is not modified by the rules DEA is finalizing today.

Regulatory
Certifications

Economic
Impact of This Rule

This rule
allows economic activity that would otherwise be prohibited. As has
now been made clear under the DEA regulations being finalized today,
all products that contain any amount of THC are schedule I
controlled substances unless they are specifically listed in another
schedule or exempted from control. Thus, without the exemptions
provided in this final rule, industrial "hemp" products such as
paper, rope, clothing, and animal feed would be subject to the
provisions of the CSA and DEA regulations that govern schedule I
controlled substances if they contained THC. The CSA permits the use
of schedule I controlled substances for industrial purposes, but
only under strictly regulated conditions. By virtue of this rule,
however, most industrial "hemp" products are exempt from all
provisions of the CSA and DEA regulations. Thus, this rule imposes
no regulatory restrictions on any economic activities; rather, it
removes regulatory restrictions on certain economic activities.

Regulatory
Flexibility Act

For the
reasons provided in the foregoing paragraph, the Acting
Administrator hereby certifies that this rule will not have a
significant impact on a substantial number of small entities within
the meaning of the Regulatory Flexibility Act (5 U.S.C. 605(b)).
Therefore, a final regulatory flexibility analysis is not required
for this final rule.

Executive
Order 12866

This rule has
been drafted and reviewed in accordance with Executive Order 12866,
Regulatory Planning and Review, section 1(b), Principles of
Regulation. This rule has been determined to be a "significant
regulatory action" under Executive Order 12866, section 3(f).
Accordingly, this rule has been reviewed by the Office of Management
and Budget for purposes of Executive Order 12866.

Executive
Order 13132

This rule
does not preempt or modify any provision of state law; nor does it
impose enforcement responsibilities on any state; nor does it
diminish the power of any state to enforce its own laws.
Accordingly, this rule does not have federalism implications
warranting the application of Executive Order 13132.

Executive
Order 12988--Civil Justice Reform

This rule
meets the applicable standards set forth in sections 3(a) and
3(b)(2) of Executive Order 12988.

Unfunded
Mandates Reform Act of 1995

This rule
will not result in the expenditure by State, local, and tribal
governments, in the aggregate, or by the private sector, of
$100,000,000 or more in any one year. Therefore, no actions are
necessary under the Unfunded Mandates Reform Act of 1995.

Small
Business Regulatory Enforcement Fairness Act of 1996

This rule is
not likely to result in any of the following: An annual effect on
the economy of $100,000,000 or more; a major increase in costs or
prices for consumers, individual industries, Federal, state, or
local government agencies, or geographic regions; or significant
adverse effects on competition, employment, investment,
productivity, innovation, or on the ability of United States-based
enterprises to compete with foreign-based enterprises in domestic
and export markets. Accordingly, under the Small Business Regulatory
Enforcement Fairness Act of 1996 (SBREFA), this is not a major rule
as defined in 5 U.S.C. 804. Therefore, the provisions of SBREFA
relating to major rules are inapplicable to this rule. However, a
copy of this rule has been sent to the Office of Advocacy, Small
Business Administration. Further, a copy of this rule will be
submitted to each House of the Congress and to the Comptroller
General in accordance with SBREFA (5 U.S.C. 801).

Paperwork
Reduction Act of 1995

This rule
does not involve collection of information within the meaning of the
Paperwork Reduction Act of 1995.

Pursuant to
the authority vested in the Attorney General under sections 201,
202, and 501(b) of the CSA (21 U.S.C. 811, 812, and 871(b)),
delegated to the Administrator and Deputy Administrator pursuant to
section 501(a) (21 U.S.C. 871(a)) and as specified in 28 CFR 0.100,
the Acting Administrator hereby orders that the interim rule
amending title 21 of the Code of Federal Regulations, part 1308, to
include new Sec. 1308.35, which was published at 66 FR 51539, on
October 9, 2001, is adopted as a final rule without change.

[Note: Selected references are a compilation of recent publications
of presumed interest to forensic chemists. Unless otherwise stated,
all listed citations are published in English. If available, the
email address for the primary author is provided as the contact
information. Listed mailing address information (which is sometimes
cryptic or incomplete) exactly duplicates that listed by the
abstracting services.]

Bradley D.
Tracking cocaine to its roots. Today's Chemist at Work
2002;May:15. [Editor's Notes: The Editor was unable to acquire a
copy of this article. However, the abstract suggests that it is an
overview of the DEA Cocaine Signature Program protocols, which
were discussed in an article published in Nature. Contact: No
address information was provided.]

The remainder
of the FY - 2003 schedule for the DEA's State and Local Forensic
Chemists Seminar is as follows:

September
15 – 19, 2003

Note that the
school is open only to forensic chemists working for law enforcement
agencies, and is intended for chemists who have completed their
agency's internal training program and have also been working on the
bench for at least one year. There is no tuition charge for this
course. The course is held in Northern Virginia, near the
Washington/Dulles International Airport. For additional information,
eligibility requirements, or to enroll, see the September 2002 issue
of Microgram Bulletin, or call 703 668-3337.

Duties:
Responsibilities will include the examination and evaluation of
scientific evidence; interpretation of laboratory analyses and
results; preparation of written reports, and the ability to testify
as an expert witness. Ancillary responsibilities include maintenance
of laboratory equipment and supplies; management of caseloads, and
attendance at workshops and seminars as required.

General
Requirements: The applicant must be skilled in using gas
chromatography, mass spectroscopy, ultraviolet and infrared
spectrophotometry and other drug screening equipment, and must be
able to work independently. Minimum requirements of the position
include, but are not limited to: Bachelor's degree in a natural
science; two years of practical working experience in a forensic
laboratory including court testimony as an expert witness; and above
average knowledge of and ability to apply scientific methods and
disciplines of laboratory testing and analysis.

Overview:
The State of Connecticut is offering you that opportunity to
create your own vision as Director of the Controlled Substances and
Toxicology Laboratory, in the Scientific Services Division,
Department of Public Safety, which has one of the most professional
and prestigious reputations in the United States. As the Chief
Toxicologist, you can focus your energies on directing staff and
operations of the laboratory, as administrative responsibilities are
shared. Your working environment will be with a highly dedicated and
professional staff supported by cutting edge tools and technology.

Duties:
We are seeking an individual with proven leadership abilities, a
passion for research and development, and the ability to complete
the laboratory accreditation process. Responsibilities include:
Directing staff and scientific operations of a forensic toxicology
laboratory; coordinates, plans and manages laboratory programs;
formulates program goals and develops laboratory policy; develops
and implements techniques necessary to examine chemical and
biological evidence; researches new methodology; reviews laboratory
findings and supervises report preparation; interprets and
administers pertinent laws; trains, supervises and evaluates staff;
responds to queries regarding drug effects and chemical actions;
serves as expert witness on relevant issues in court cases; and
performs related duties as required.

Qualifications: A minimum of 10 years experience and training in
toxicology and criminalistics in a public health or general
toxicology laboratory. Two years of this experience must have been
in a supervisory capacity in a major program in forensic toxicology.
You must have a comprehensive understanding of the principles and
techniques of analytical chemistry (to include infrared and ultra
violet spectrophotometry, gas and high performance liquid
chromatography, mass spectrometry, and immunoassays). Also, a
comprehensive knowledge of the principles of pharmacokinetics and
pharmacodynamics is required. Passing an extensive background check
is a hiring requirement. The ideal candidate will have a Ph.D. in
Toxicology, pharmacology, or related biological or chemical science
and will be Board Certified or eligible for Board Certification in
Forensic Toxicology.

In addition
to a competitive salary, the State of Connecticut total compensation
plan includes a generous benefit package worth over 36% of an
employees' annual salary. Benefits and options include: A choice of
medical and dental plans designed to suit your need, long and short
term disability, life insurance, an excellent retirement plan,
deferred compensation plan, 12 paid holidays, personal leave days,
sick time, and a generous vacation plan. For more information go to:
www.das.state.ct.us.

If there is
a constant in the world of forensic science, it is the plea for
more resources. The usual justifications typically utilize "shock
statements" concerning the dramatic increases of exhibits being
submitted for examination and the concomitant rapid increases in
evidence backlogs.

Not
surprisingly, digital evidence programs are no exception – and in
fact, they are often leading the charge on "shock statements".
Currently, submission rates for digital evidence laboratories are
growing between 20 and 60 percent per year, and examination
backlogs are typically averaging between 2 and 9 months! Even the
most limited computer examinations take 3 to 5 days, and in-depth
analyses can take 2 to 3 weeks. When compared to most other
forensic sciences, digital evidence is a high-pressure and
labor-intensive endeavor, with significant operational issues
(backlogs, turnaround times, mission creep, etc.) and critical
infrastructure problems (lack of examiners, lack of space,
continuous need for updated software and hardware, etc.).
Alternative solutions such as automation or intelligent software
do not appear to offer much promise, at least in the near term.

Not
surprisingly, this situation is highly frustrating for management
and budget planners. From their perspective, digital evidence
programs represent a serious "problem" that (much more often than
not) is getting ever-worse despite the ever-increasing input of
additional resources. And there's seemingly no end in sight.

Despite
these issues, however, virtually every Federal law enforcement
organization, and also many state and local crime laboratories
and/or investigative agencies, have established digital evidence
programs. Why? The answer is simple: Results, Results, and more
Results. Management continues to support digital evidence
because the tangible benefits derived from the program clearly
outweigh its costs and growing pains. And doing nothing is simply
not an option.

The recent
establishment of the DEA Digital Evidence Laboratory forced DEA
management to look at the big picture and evaluate what works,
what needs to be improved, and what is the overall impact of the
program. As part of this review, a survey of 22 Case Agents that
recently (within the last 9 months) had one or more exhibits
analyzed by a DEA digital evidence examiner was conducted. The
purpose of the survey was to quantify the value that the
examination had in each case. This was not, of course, a broad,
scientific sampling. Rather, the interest was in gaining a quick
insight into how digital evidence examination results are actually
used, and assessing the value of the examinations to the
respective cases. The survey was almost equally divided between
drug enforcement cases (clandestine laboratory operators, money
launderers, drug importers, and drug traffickers) and drug and
chemical diversion investigations (doctors, pharmacies, drug
manufacturers, wholesalers, and chemical companies).

The
findings documented that the examinations made several significant
contributions to the cases. In fact, the average number of
positive outcomes mentioned by Case Agents was five! Table 1 (next
page) lists some of the outcomes and their reported frequency as
stated by Agents.

Table 1:
DEA Case Agent Survey Results

Outcome
Mentioned

Frequency

Corroborate Prior Investigative Information

90%

Used As
Drug Intelligence

70%

Provided
Investigative Leads

70%

Identified
Incriminating Information

65%

Verified
Informant Statement

60%

Identified
Overt Illegal Acts

50%

Identified
Trafficker Financial Information

40%

Used in
Plea Negotiation

40%

Identified
Previously Unknown Co-conspirator

35%

Most
importantly, 40% of the Agents reported that the digital evidence
examination support was "essential" to their investigation.
Another 30% reported the support rendered was "very important".
Overall, 95% of the Agents indicated satisfaction with the support
provided by the digital evidence laboratory.

The value
of this information is three-fold. First, it formally documents
how the digital evidence program supports DEA Agents who are
investigating drug cases. Second, it shows how forensic support is
particularly well suited for identification of illegal acts,
co-conspirators, and trafficker financial assets. Third, the fact
that 40% of the Agents indicated that it was "essential" to their
case strongly suggests that their cases may have had very
different outcomes had it not been for the digital evidence
examination.

Different
law enforcement organizations would likely have different results
from a similar survey of their digital evidence programs. These
differences would reflect the varied nature of crime, and the
varied use of digital technologies in illicit activities.

Surveying
your "customers" (Case Agents) is a very good idea. The
information obtained can assist in making the case (i.e.,
documenting) that a digital evidence program really does provide
value, and justifies the need for additional resources. And it is
usually better to accentuate the positive, actual results, versus
harping on the gloom and doom of evidence backlogs, or using
"shock statements" concerning the incredible numbers of computers,
Internet accounts, and electronic consumer devices in the world.
The latter numbers are now so large that they have become almost
meaningless anyway.